[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-tract-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-tract-infections":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,45,70,82,114,143,167,195,237,254,282,304,324,354,383,405,434,483,505,530,552],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100053455","phase-4-the-lalelalung-study-digital-stethoscope-clinical-evaluation-100053455",false,"NCT07631377","The LalelaLung Study: Digital Stethoscope Clinical Evaluation","LaLeLa","Inclusion Criteria:\n\n* Age 2 to 59 months at the time of screening\n* Presence of cough and\u002For difficulty breathing\n* No WHO-defined emergency\u002Fdanger signs (e.g., grunting, cyanosis, apnea, convulsions, or altered level of consciousness)\n* A legal caregiver is present, able to understand the study information, and willing to provide written informed consent\n* Caregiver is willing and able to provide contact information (e.g., mobile phone number) to allow 7-day follow-up after the clinic visit\n\nExclusion Criteria:\n\n* Presence of WHO-defined emergency signs requiring immediate referral or hospital admission (grunting, cyanosis, apnea, uncompensated shock, convulsions, diarrhea with severe dehydration, or altered level of consciousness)\n* Critical illness or clinical instability judged by the screening clinician or study physician to require urgent medical attention\n* Age outside the target range (younger than 2 months or older than 59 months)\n* Previous enrollment in the study\n* Refusal or withdrawal of informed consent by the legal caregiver at any time prior to randomization","ALL","2 Months","59 Months",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance.\n\nNew digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and\u002For difficult breathing at a primary care clinic in Cape Town, South Africa.\n\nThe main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter.\n\nA separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows.\n\nThroughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.",[27,28,29,30,31,32],"Pneumonia","Tuberculosis, Pulmonary","Respiratory Tract Infections","Bronchiolitis","Respiratory Sounds","Antibiotic Resistant Strain","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-08-17",{"date":41,"type":21},"2028-06-30",{"name":43,"class":44},"Johns Hopkins University","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":66,"locationsCount":69},"100490046","novel-technologies-for-respiratory-virus-identification-100490046","NCT05661032","Novel Technologies for Respiratory Virus Identification","ResVir Novel Technologies for Respiratory Virus Identification","ResVir","Inclusion Criteria:\n\n* Provide informed, (parental\u002Fguardian, where appropriate) consent\n* Able to provide nasopharyngeal swab\u002Faspirate specimens.\n* A clinical suspicion of a respiratory viral infection with one or more of the following symptoms:\n* Coryzal symptoms (runny nose, sneezing and\u002For nasal congestion)\n* New onset of cough\n* Sore throat\n* Head and\u002For Muscle aches\n* Fever or chills\n\nExclusion Criteria:\n\n* Unable to comply with study procedures or where in the opinion of the investigator, undertaking a nasopharyngeal swab may be detrimental to the individual\n* Lacking capacity to consent",{"count":54,"type":21},1000,"OBSERVATIONAL","Current virus detection methods often take significant time or can be limited in sensitivity, specificity or cost. There is therefore a need for diagnostic methods that are simple to use, sensitive, rapid and inexpensive.\n\nThis is a proof of concept study to determine whether the Pictura Bio system (a new a rapid pathogen identification technology) is able to detect and differentiate different viruses from nasopharyngeal swabs\u002Faspirate specimens. The data collected will be used to \"train\" the algorithms to be able to accurately identify respiratory viruses. The accuracy with which the algorithms estimate the test dataset will be monitored at regular intervals during the training dataset collection period. The Pictura Bio system is still under development, which means that it is still \"learning\". The system needs to see more information so that it can be sufficiently accurate to be used in clinical practice and should become more accurate in identifying these viruses as it sees more and more information from patients.\n\nThis study will take place at Portsmouth Hospitals University NHS Trust and aims to recruit 1000 patients. To do this, we will recruit both adults and children who either present to the emergency department or are admitted to QAH with a clinical suspicion of a respiratory viral infection. All participants will have a nose and\u002For throat swab taken as part of their clinical assessment, and we would ask to take a further nasal swab for the purpose of the study. Research sampling will be combined with routine clinical samples where possible to reduce the frequency of testing. We will use most of the information to teach the system how to become more accurate at identifying respiratory viruses. We will keep the remaining information separate and use it to test how accurate the system is. All of the data will be kept securely. Basic information will be collected including age, gender, results of blood tests taken for clinical review, treatment and outcome data. No results from the swabs taken for the purpose of the study will be available to either the participant or the clinical team and the information will have no effect on patient care.",[58,29],"Infections, Respiratory","RECRUITING","2026-06-26",{"date":62,"type":37},"2026-06-30",{"date":64,"type":37},"2023-01-18",{"date":62,"type":21},{"name":67,"class":68},"Portsmouth Hospitals NHS Trust","OTHER_GOV",1,{"id":71,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":25,"conditions":74,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":81,"locationsCount":4},"100643415",{"count":20,"type":21},[24],[27,28,29,30,31,32],"2026-06-05",{"date":77,"type":37},"2026-06-09",{"date":79,"type":21},"2026-07-20",{"date":41,"type":21},{"name":43,"class":44},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":69},"100633919","phase-4-clinical-efficacy-of-stopping-oral-antibiotics-when-symptoms-stop-compared-to-finishing-the-course-100633919","NCT07532941","Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'","StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)","StopStop@HITH","Inclusion Criteria:\n\n1. Between the ages of ≥ 1 years and ≤ 17 years at enrolment\n2. Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis\n3. Prescription of oral antibiotics as a switch from IV antibiotics\n\nExclusion Criteria:\n\n1. Clinician determined need for \\>10-day oral antibiotic course\n2. Child with immunosuppression (e.g. as a result of cancer treatment)\n3. Second episode of same bacterial infection within the last 28 days\n4. Child is unable to take oral antibiotics\n5. Previous enrolment in StopStop@HITH\n6. Parent\u002Fguardian does not speak English\n7. Clinician determined need for 10-day course of oral antibiotics for treatment\u002Fclearance of streptococcal infection\n8. UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)\n9. LRTI only: known chronic respiratory condition (e.g. cystic fibrosis or bronchiectasis) or need for long term respiratory support (e.g. home oxygen, Continuous Positive Airway Pressure \\[CPAP\\] or tracheostomy); empyema or lung abscess","1 Year","17 Years",{"count":93,"type":21},200,[24],"The aim of the StopStop@HITH study is to see if stopping antibiotics when symptoms stop is as good as finishing the course of antibiotics. The study will enrol children at the Royal Children's Hospital who are prescribed oral antibiotics after completing a course of intravenous (IV) antibiotics for the treatment of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) and lymphadenitis.\n\nThe aims of the study are:\n\n* To determine if oral antibiotics can be safely stopped once symptoms stop in children with cellulitis (who have completed a course of IV antibiotics).\n* To assess feasibility of a larger study of other common infections across multiple hospitals.\n\nThe participants parent\u002Fguardian will complete a daily symptom tracker for the duration of the prescribed oral antibiotic course and attend a telehealth appointment with the study team once the participants symptoms have resolved. There are additional follow up surveys at day 14, day 28 and day 180.",[97,98,29,99],"Urinary Tract Infection","Cellulitis","Lymphadenitis",[101,102,103,104],"Infection","Antibiotics","Paediatrics","Symptom Guided","2026-04-08",{"date":107,"type":37},"2026-04-16",{"date":109,"type":21},"2026-06",{"date":111,"type":21},"2028-06",{"name":113,"class":44},"Murdoch Childrens Research Institute",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100571058","intravenous-versus-oral-treatment-of-the-main-acute-infections-100571058","NCT06715306","Intravenous Versus Oral Treatment of the Main Acute Infections","Intravenous Versus Oral Treatment of the Main Acute Infections in Emergency Departments","Inclusion Criteria:\n\n* Suspected respiratory tract infection, urinary tract infection, or cellulitis by the attending physician\n* Planned or initiated intravenous antibiotic treatment\n\nExclusion Criteria:\n\n* if received more than two doses of intravenous antibiotics;\n* systolic blood pressure \\\u003C90 mmHg;\n* nausea and\u002For vomiting in more than one short-term instance during the last 2 days;\n* suspected significantly reduced gastrointestinal absorption;\n* confirmed plasma-lactate \\> 2;\n* pregnant or nursing;\n* unable to give informed consent;\n* severe immunodeficiency;\n* urgent vital treatment needed.","18 Years",{"count":123,"type":21},4000,[125],"NA","Patients admitted to the hospital with acute infections are often treated with intravenous (IV) antibiotics. Around 70% of these infections fall into three categories: respiratory tract infections, urinary tract infections, and cellulitis. A Danish study found that 76% of patients admitted with suspected community-acquired pneumonia and treated with antibiotics received them intravenously. Based on an extrapolated estimate from an unpublished local survey, approximately 50,000 patients in Denmark are admitted each year for infections and treated with IV antibiotics. The average hospital stay for these patients is 5.9 days, resulting in a total of 295,000 hospital days annually, accounting for about 7% of total hospital admissions in Denmark. This represents an annual cost of 2.3 billion DKK. While some patients need hospitalization due to their overall health or other serious conditions, others remain hospitalized primarily to receive IV antibiotics.\n\nExpanding the use of oral antibiotics in emergency departments should be pursued only if it can demonstrate comparable efficacy and safety to IV administration. Therefore this study will investigate the efficiency of primarily oral antibiotics in acutely admitted patients with proven or suspected infections. Additionally, the investigators will evaluate the safety of oral regimen for these patients.",[29,128,98],"Urinary Tract Infections",[130,131,132],"Oral antibiotic therapy","intravenous antibiotic therapy","intravenous-to-oral-switch","2026-03-03",{"date":135,"type":37},"2026-03-05",{"date":137,"type":37},"2025-01-15",{"date":139,"type":21},"2028-01-06",{"name":141,"class":44},"University of Southern Denmark",7,{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":69},"100521522","an-adjunct-test-distinguishing-bacterial-from-viral-etiology-improves-resource-utilization-and-efficiency-in-the-ed-100521522","NCT06070688","An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.","Does an Adjunct Diagnostic Test That Can Discriminate Bacterial From Viral Etiology Early in the Management of Respiratory Infections Improve Management Accuracy and Quality in the Acute Care Setting?","Inclusion Criteria for main study population :\n\n* Current disease duration ≤ 7 days\n* Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days\n* Clinical suspicion of bacterial or viral respiratory tract infection (RTI)\n\nExclusion Criteria for main study population:\n\n* Systemic antibiotics taken up to 48 hours prior to presentation\n* Outpatient steroids taken within 48 hours prior to presentation\n* Suspicion and\u002For confirmed diagnosis of infectious gastroenteritis\u002Fcolitis\n* Inflammatory disease\n* Congenital immune deficiency (CID)\n* A proven or suspected infection on the presentation with Mycobacterial, parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen\n* Human immunodeficiency virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)\n* Major trauma and\u002For burns in the last 7 days\n* Major surgery in the last 7 days\n* Pregnancy - Self reported or medically confirmed\n* Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission.\n* Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days\n* Hemodynamically unstable (require life-saving interventions such as vasopressors)\n* Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)\n* Consider unsuitable for the study by the study team\n\nInclusion Criteria for Subgroup:\n\n* Written informed consent must be obtained from the patient or his\u002Fher legal guardian\n* Current disease duration ≤ 7 days\n* Clinical suspicion of bacterial or viral sepsis based on 2 or more SIRS criteria OR Clinical suspicion of bacterial or viral respiratory tract infection (RTI) AND temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days\n\nPatients fulfilling one or more of the following exclusion criteria from the main group are eligible for the subgroup cohort:\n\n* Systemic antibiotics taken up to 48 hours prior to presentation\n* Outpatient steroids taken within 48 hours prior to presentation\n* Suspicion and\u002For confirmed diagnosis of infectious gastroenteritis\u002Fcolitis\n* Inflammatory disease (e.g., IBD, SLE, RA, other vasculitis)\n* Congenital immune deficiency (CID)\n* A proven or suspected infection on the presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen\n* HIV, HBV, or HCV infection (self-declared or known from medical records)\n* Major trauma and\u002For burns in the last 7 days\n* Major surgery in the last 7 days\n* Pregnancy - Self reported or medically confirmed\n* Active malignancy of a solid tumor - Cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission\n* Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days\n* Hemodynamically unstable (require life-saving interventions such as vasopressors)\n* Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results)",{"count":151,"type":21},100,[125],"The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)",[29],[156,157],"bacterial infection","viral infection","2026-01-21",{"date":160,"type":37},"2026-01-23",{"date":162,"type":37},"2023-12-11",{"date":164,"type":21},"2026-12-31",{"name":166,"class":44},"The University of Texas Health Science Center, Houston",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":174,"sex":16,"minAge":121,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":180,"conditions":181,"keywords":184,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":69},"100608879","phase-1-phase-i-study-of-singlemultiple-ascending-doses-of-jkn2501-for-injection-in-chinese-healthy-volunteers-100608879","NCT07207291","Phase I Study of Single\u002FMultiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers","Inclusion Criteria:\n\n* Voluntary informed consent; able to comply with study requirements and communicate effectively.\n* Healthy subjects aged 18-45 years (inclusive) at screening.\n* BMI 19.0-26.0 kg\u002Fm² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).\n* Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.\n* Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm\u002Fegg donation plans during this period.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.\n* Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.\n* Use of drugs known to inhibit\u002Finduce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.\n* Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.\n* History of febrile illness or active infection within 2 weeks prior to screening.\n* Blood loss\u002Fdonation \\>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.\n* History of significant food\u002Fdrug allergy, or allergy to JKN2501\u002Fexcipients.\n* Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.\n* Smoking ≥5 cigarettes\u002Fday within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.\n* History of drug abuse; positive urine drug screen at baseline (Day -1).\n* Positive alcohol breath test at baseline (Day -1).\n* Participation in another interventional clinical trial within 3 months prior to screening or planned during this trial.\n* Estimated glomerular filtration rate (eGFR) \\\u003C90 mL\u002Fmin.\n* Serum total calcium below lower limit of normal at screening.\n* Investigator-determined unsuitable venous access for PK sampling\u002Finfusion, or history of adverse symptoms\u002Fphobias related to infusion\u002Fphlebotomy.\n* Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.\n* Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods\u002Fbeverages within 48h prior to first dose; inability to abstain during the trial.\n* History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening\u002Fbaseline.\n* Any other condition deemed by the investigator to make the subject unsuitable for participation.",true,"45 Years",{"count":177,"type":21},66,[179],"PHASE1","This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts:\n\nPart 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis.\n\nPart 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults.\n\nDose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.",[182,128,183,29],"Bacterial Infections","Intra-Abdominal Infections",[182],"2025-09-28",{"date":187,"type":37},"2025-10-03",{"date":189,"type":37},"2025-08-22",{"date":191,"type":21},"2026-03-19",{"name":193,"class":194},"Joincare Pharmaceutical Group Industry Co., Ltd","INDUSTRY",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":174,"sex":203,"minAge":121,"maxAge":175,"enrollmentInfo":204,"targetDuration":4,"studyType":22,"phases":206,"briefSummary":208,"conditions":209,"keywords":220,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":69},"100559957","phase-3-vitamin-d-in-pregnancy-for-prevention-of-early-childhood-asthma-100559957","NCT06570889","VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma","VItamin D in pregnanCy for prevenTion Of eaRlY Childhood Asthma (VICTORY)","VICTORY","* Pregnant Danish women before week 26 with blood levels of EPA+DHA above 4.7% of total fatty acids\n* No current vitamin D intake above the recommended 400 IU\u002Fday\n* No endocrine-, heart-, kidney- or auto-immune disorders\n* No disorders requiring treatment with blood thinning medication","FEMALE",{"count":205,"type":21},2000,[207],"PHASE3","The overall aim of the study is to develop a nutritional preventive vitamin D supplementation strategy in pregnancy for early childhood asthma\u002Fpersistent wheeze during the first three years of life as we hypothesize that supplementation in higher doses than recommended could reduce the risk of disease development.",[210,29,211,212,213,214,215,216,217,218,219],"Asthma","Gastrointestinal Infection","Croup","Eczema","Allergy","Wheezing","Fractures, Bone","Development, Child","Cognition Disorders in Children","Psychiatric Diagnosis",[221,210,222,213,214,223,224,225,226,227],"Childhood","Infections","Development","Psychiatry","Bone development","Cognition","Growth","2025-09-24",{"date":230,"type":37},"2025-09-30",{"date":232,"type":37},"2024-12-20",{"date":234,"type":21},"2033-03",{"name":236,"class":44},"Professor Klaus Bønnelykke",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":174,"sex":203,"minAge":121,"maxAge":175,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":246,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":252,"leadSponsor":253,"locationsCount":69},"100559140","phase-3-fish-oil-in-pregnancy-for-personalized-prevention-of-early-childhood-asthma-100559140","NCT06560255","Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma","Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma (FREYA)","FREYA","* Pregnant Danish women before week 26 with blood levels of EPA+DHA below 4.7% of total fatty acids\n* No planned use of fish oil supplementations\n* No endocrine-, heart-, kidney- or auto-immune disorders\n* No disorders requiring treatment with blood thinning medication",{"count":205,"type":21},[207],"The overall aim of the study is to develop a nutritional preventive fish oil supplementation strategy in pregnancy for early childhood asthma\u002Fpersistent wheeze during the first three years of life as we hypothesize that both supplementations in higher doses than recommended could reduce the risk of disease development.",[210,29,211,212,213,214,215,216,217,218,219],[221,210,222,213,214,223,224,225,226,227],{"date":230,"type":37},{"date":232,"type":37},{"date":234,"type":21},{"name":236,"class":44},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":262,"maxAge":91,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":272,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":69},"100600150","perspectives-on-antibiotics-and-tracking-symptoms-in-children-100600150","NCT07093749","Perspectives on Antibiotics and Tracking Symptoms in Children","PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study","PATSy","Inclusion Criteria:\n\n* Between the ages of ≥ 4 years and ≤ 17 years at enrolment.\n* Diagnosed with any of the following at RCH ED: urinary tract infection (UTI), cellulitis, impetigo, pharyngitis, tonsillitis, respiratory tract infections, otitis media.\n* Prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care due to having uncomplicated infection as deemed by their treating doctor.\n* Parent\u002Fguardian provides a signed and dated informed consent form.\n\nExclusion Criteria:\n\n\\- Parent\u002Fguardian does not speak English","4 Years",{"count":264,"type":21},300,[125],"The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \\[via questionnaires\u002Fsurveys and from the Garmin Smartwatches\\] through a singular platform).",[97,98,268,269,270,29,271],"Impetigo","Pharyngitis","Tonsillitis","Otitis Media",[103,102,273,101],"Digital Health","2025-09-17",{"date":276,"type":37},"2025-09-22",{"date":278,"type":37},"2025-09-16",{"date":280,"type":21},"2026-08",{"name":113,"class":44},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":174,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":69},"100519129","tino-t-cells-in-the-nose-of-older-adults-100519129","NCT06039527","TINO: T Cells in the Nose of Older Adults","TINO: Identifying the Underlying Mechanisms and Consequences of the Loss of Nasal T Cells in Vital and Frail Older Individuals","TINO","Inclusion Criteria:\n\n•Adults able and willing to provide informed consent.\n\nSpecific inclusion criteria per group:\n\n* Young adults aged 18-30 years old\n* Healthy elderly aged \\>65 years old\n* Frail elderly \\>65 years old\n* Clinical Frailty score healthy elderly 1-3\n* Clinical Frailty score frail elderly \\>3\n* Self-reported respiratory tract infection in previous year healthy elderly 0-1\n* Self-reported respiratory tract infection in previous year frail elderly 0-1 or \\>1\n\nExclusion Criteria:\n\n* Incompetence to provide informed consent prior or during study\n* Current smoker or \\>40 pack year history\n* History of severe nose bleedings\n* Diagnosed with asthma, COPD or chronic rhinosinusitis\n* Use of inhalation corticosteroids or antibiotics in the past 6 weeks\n* Current use of anti-coagulants (to prevent nosebleeds). Platelet inhibitors like acetylsalicylzuur (Ascal) are allowed.\n* Respiratory tract infection or common cold in the past 2 weeks\n* Immunocompromised individuals (with primary immune deficiency or secondary immune deficiency)\n* Life expectancy \\\u003C28 days in the opinion of study physician\n* Vaccination in the 2 months prior to study start. A potential subject that is only excluded from participation based on a recent vaccination will be asked to re-participate 2 months post vaccination.",{"count":291,"type":21},170,"Rationale: Individuals with advanced age are at a progressively increasing risk of acquiring lower respiratory tract infections. Besides calendar age, the degree of frailty also associates with increased susceptibility to pneumonia requiring hospitalization. How alterations in the mucosal immune system with advanced age predispose to infections remains unclear as access to relevant tissue samples is limited. With minimally-invasive nasal sampling methods, it was recently observed that in vital older adults, both CD4+ T cells and CD8+ T cells are selectively lost from the nasal mucosa. However, the exact phenotype, underlying mechanisms, key molecules and consequences of this have not yet been investigated.\n\nObjective:\n\nElucidate the mechanisms underlying the loss of nasal T cells and characterize in depth the differences of T cells in young and older adults and associate this loss with susceptibility to infections.\n\nStudy design: Prospective cohort study\n\nStudy population: Participants will be recruited from 3 groups:\n\n* healthy young adults (18-30 years, n=50)\n* vital older adults (\\>65 years, n=60)\n* frail elderly (\\>65 years, n=60). This group includes individuals without a history of recurrent respiratory infections or with \\>2 self-reported episodes of respiratory infection in the past year.\n\nMain study parameters\u002Fendpoints: Frequency of nasal CD8+ T cells in young adults and frail older adults.\n\nSecondary study parameters\u002Fendpoints:\n\n* Phenotype (subsets, activation status), functionality, transcriptomic state, clonality and frequency of nasal and blood T cell populations\n* Stability of T cells and other immune parameters, as described for main study parameter, during a second sample after 3 months.\n* Analysis of other immune populations as for main study parameter\n* Concentration of nasal and systemic factors (e.g. cytokines and metabolites) and their association with T cells and other immune populations\n* Respiratory tract microbiota profiles and presence of asymptomatic viral infections and their association with T cells and other immune parameters\n* Chronological and biological age, sex, and other immunologically relevant parameters with T cell populations and other immune parameters\n* Alteration of T cell phenotype, during and following respiratory tract infections. Levels of antigen-specific T cells and other immune parameters in nose and blood post infection.",[29,294],"Aging","2025-09-02",{"date":297,"type":37},"2025-09-09",{"date":299,"type":37},"2021-01-24",{"date":301,"type":21},"2026-05",{"name":303,"class":44},"Leiden University Medical Center",{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":69},"100569441","the-role-of-chest-ultrasound-in-patients-with-respiratory-tract-infections-100569441","NCT06694285","The Role of Chest Ultrasound in Patients With Respiratory Tract Infections","Observational Study on the Role of Chest Ultrasound in Patients With Respiratory Tract Infections","REPSECO","Inclusion Criteria:\n\n* Patients aged 0 to 20 years with a clinical diagnosis of respiratory tract infection, evaluated in the emergency department and then discharged home or admitted to the Pediatric Intensive Care Unit or Pediatrics Department.\n* Informed consent signed by parents or patient of legal age\n\nExclusion Criteria:\n\n* Refusal to sign informed consent\n* Patients with bronchopulmonary dysplasia\n* Foreign body aspiration cases\n* Patients with pulmonary malformations\n* Patients with neuromuscular diseases\n* Patients with hemodynamically significant congenital heart disease","20 Years",{"count":264,"type":21},"Respiratory tract infections are a major cause of hospitalization among pediatric and adult patients, regardless of the cause, whether viral or bacterial. It is critical to stratify each patient's risk to predict the subsequent clinical course. Point-of-care chest ultrasonography in parallel with clinical evaluation has been found to be an effective tool to assess the severity of pathology. A number of scores have been validated on the basis of the ultrasound picture. Currently, a growing interest is directed toward the unambiguous validation of an ultrasound score that can predict the patient's outcome in terms of hospitalization, ICU admission, need for a more pronounced approach in terms of respiratory care both qualitatively and quantitatively.",[29],"2025-08-25",{"date":295,"type":37},{"date":319,"type":21},"2025-09-01",{"date":321,"type":21},"2028-03-31",{"name":323,"class":44},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":340,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100442763","phase-4-antibiotic-therapy-in-viral-airway-infections-100442763","NCT05045612","Antibiotic Therapy in Viral Airway Infections","Antibiotic Therapy in Viral Airway Infections: An Open Labeled Randomized Controlled Pragmatic Trial to Evaluate the Efficacy and Safety of Discontinuing Antibiotic Therapy in Adult Patients With Respiratory Viruses","ATHENIAN","Inclusion Criteria:\n\n* Hospitalized\n* Adults 18 year or older\n* Moderately severe disease (CRB65 ≤ 2 at time of inclusion)\n* Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)\n* On antibiotic therapy as instituted by the receiving physician from the emergency department\n* Signed informed consent must be obtained and documented according to ICH GCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Requiring ICU admission at screening\n* Requiring high-flow oxygen therapy or non-invasive ventilation at screening\n* Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)\n* Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant)\n* SARS-CoV-2 positive\n* Bacteremia\n* Urine antigen test positive for legionella\n* Any other infection necessitating antibiotic treatment\n* Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital\n* Time from initiation of antibiotic therapy to screening \\>48 hours",{"count":333,"type":21},380,[24],"Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses.\n\nA general recommendation to treat all instances of community acquired pneumonia (CAP) patients with antibiotics leads to significant antibiotic overtreatment. In 2008, the US Food and Drug Administration approved the first multiplex polymerase chain reaction assay for the detection of multiple respiratory virus nucleic acids simultaneously. The wide availability of such nucleic acid amplification tests (NAAT) for rapid viral detection together with chest radiographs has the potential to define patients who can be managed without antibiotics.\n\nAkershus University Hospital is one of the largest hospitals in Norway, with a catchment area of more than 550,000 people. In 2012 to 2013, the majority of patients admitted to Akershus University Hospital with suspected CAP and a positive viral NAAT were treated with antibiotics, a prescription pattern representing antibiotic overtreatment. The investigators accordingly hypothesize that discontinuation of antibiotic therapy in patients with moderately severe disease and airway sample positive for respiratory viruses is safe and non-inferior to continuation of antibiotic therapy.",[337,338,339,29],"Infectious Disease","Influenza","Respiratory Syncytial Virus (RSV)",[341,342,343],"pragmatic trial","antibiotic stewardship","viral respiratory tract infection","2025-08-11",{"date":346,"type":37},"2025-08-12",{"date":348,"type":37},"2022-01-13",{"date":350,"type":21},"2029-11",{"name":352,"class":44},"University Hospital, Akershus",12,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":361,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":22,"phases":365,"briefSummary":366,"conditions":367,"keywords":371,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":381,"locationsCount":69},"100554125","how-omt-benefits-newly-diagnosed-patients-with-respiratory-illness-when-given-alongside-other-standard-care-100554125","NCT06495021","How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.","OMT and Respiratory Illness","Inclusion Criteria:\n\n* Patients being seen for respiratory illness symptoms at Geisinger 65-Forward Buckhorn, PA clinic for care.\n* Patients age of 65-100\n* New diagnosis of upper respiratory illness, sinusitis, bronchitis, or pneumonia during outpatient visit.\n\nExclusion Criteria:\n\n* Patients that have a healing fracture, including the spine, pelvis, shoulder, ribs, vertebrae, or extremities.\n* Patients actively receiving any type of cancer treatment\n* Patients with active or previously diagnosed liver disease.","65 Years","100 Years",{"count":364,"type":21},68,[125],"This study is to see Osteopathic Manipulative Therapy, or OMT, can aid in treating patients being seen for respiratory illness and associated symptoms. The hypothesis is that the addition of OMT therapy, alongside other standard care (such as a medication), can help lessen patient symptoms sooner than just other treatment alone, and the duration of the condition will shorten as well.",[27,368,369,370,29],"Sinusitis","Bronchitis","Respiratory Disease",[372,373,374],"Osteopathic Manual Therapy","Respiratory Illness","OMT","2025-07-07",{"date":377,"type":37},"2025-07-08",{"date":379,"type":37},"2024-12-31",{"date":109,"type":21},{"name":382,"class":44},"Geisinger Clinic",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":390,"targetDuration":391,"studyType":55,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":69},"100552036","predicting-ventilator-associated-lower-respiratory-tract-infection-outcomes-using-sequenced-based-early-microbiological-response-100552036","NCT06467864","Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response","Predicting Ventilator-associated Lower Respiratory Tract Infection Outcomes Using Sequenced-based Early Microbiological Response: A Multi-center Prospective Study","Inclusion Criteria:\n\n* Aged 18 years and above.\n* Previously relied on mechanical ventilation (endotracheal intubation or tracheotomy) for breathing assistance, and the duration of mechanical ventilation was more than 48h.\n* Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 12\\*10\\^9\u002FL or less than 4\\*10\\^9\u002FL), and the presence of purulent tracheal secretions.\n\nExclusion Criteria:\n\n* Bronchoscopy and respiratory specimen collection were not performed at screening (Day 1) and after 3 days of treatment (Day 4).\n* Refusal of patients or families to participate in the study\n* After initial screening, bronchoscopy was performed to obtain BALF for bacterial culture. The results of the culture showed no evidence of infection by study-associated lower respiratory pathogens.\n\nNote: The evidence of infection was defined as a single positive bacterial culture (pathogen quantification ≥10\\^4 cfu\u002Fml or \"++\" and more) on Day1. And the study-associated causative pathogens are Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, and Staphylococcus aureus. Additionally, the included patient must have single infection with one of these pathogens.",{"count":93,"type":21},"28 Days","We are using a tool called QtNGS (quantitative targeted amplicon-based next-generation sequencing ) to measure the abundance of local pathogens in patients with ventilator-associated lower respiratory tract infections. We hypothesize that changes in pathogen abundance before and after treatment are related to patient outcomes. This study aims to evaluate the effectiveness of the tool by analyzing the changes in pathogen abundance and exploring the relationship between these changes and clinical outcomes.",[394,29,395],"Pneumonia, Ventilator-Associated","Prognosis","2025-05-22",{"date":398,"type":37},"2025-05-23",{"date":400,"type":37},"2024-04-01",{"date":402,"type":21},"2026-01-29",{"name":404,"class":44},"The First Affiliated Hospital with Nanjing Medical University",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":69},"100552371","phase-3-predicate-trial-for-respiratory-tract-infections-100552371","NCT06472219","PREDICATE Trial For Respiratory Tract Infections","Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial","Inclusion Criteria:\n\nPatients will be eligible for the study if ALL the following are present:\n\n1. Adults ≥18 years of age; AND\n2. scARI; AND\n3. Intended hospitalisation; AND\n4. No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he\u002Fshe were to participate in the trial\n\nExclusion Criteria:\n\nPatients will be excluded if the treating clinician considers that the patient is not suitable for the trial.\n\nPatients may be excluded if any ONE of the following are present:\n\n1. Vulnerable subjects (pregnancy; cognitively impaired; prisoners; students; umemployee; minorities);\n2. Cardiac arrest or post-cardiac arrest ROSC;\n3. Not expected to survive 3 days due to pre-existing chronic disease;\n4. Palliative (comfort) care\n5. Undergoing active cancer therapy;\n6. Neutropenia due to chemotherapy\u002Fmalignancy (but not due to sepsis)\n7. Immunocompromised or being treated with immunotherapy\n8. Organ transplantation\n9. HIV and on HIV drugs (indinavir, atazanavir, nelfinavir, saquinavir, ritonavir)\n10. Recent Surgery (within one month)\n11. Dialysis (including CAPD)\n12. Diabetic ketoacidosis\n13. Acute asthma\n14. Recurrent chest infection,\n15. Cushing's or Addisonian's disease,\n16. Long term systemic steroid\n17. Long-term antibiotics",{"count":413,"type":21},1300,[207],"Background\n\nThe goal of this clinical trial is to learn if prednisolone works to treat moderate to severe respiratory tract infections in adults admitted to hospital. It will also learn about the safety of prednisolone in this context. The main questions it aims to answer are:\n\nDoes prednisolone lower the number of participants who develop sepsis or who survive? What medical problems do participants have when taking prednisolone? Researchers will compare prednisolone to a placebo (a look-alike substance that contains no drug) to see if prednisolone works to treat respiratory tract infections in adults.\n\nParticipants will:\n\nTake prednisolone 30mg or a placebo every day for 5 days. Complete a daily diary of symptoms for 30 days and have telephone follow up. Investigators propose to recruit 1300 patients, 650 in each group. The Trial will be conducted in the Emergency Departments and wards of hospitals in Hong Kong.\n\nInvestigators expect the proportion of patients admitted to the hospital who develop sepsis or who die within 30 days to be reduced from 25% to 18% after taking active treatment. Secondly, investigators expect any difference in the proportion of patients with Serious adverse events(SAEs) not to exceed 5% between active treatment group and control.\n\nBenefits to Hong Kong and Worldwide: Active treatments (e.g. prednisolone are cheap, HK$0.2 per 5mg tablet) are widely available across the world. Any reduction of progression to sepsis and death if applied worldwide would improve the lives of millions of patients and save millions of dollars of healthcare costs.",[29],[418,419,420,27,421,422,29,423,424,425],"Emergency Care","Inflammation","Mortality","Prednisolone","Randomised Controlled Trial","Safety","Sepsis","Steroids","2025-01-13",{"date":137,"type":37},{"date":429,"type":37},"2024-12-23",{"date":431,"type":21},"2028-12-08",{"name":433,"class":44},"The University of Hong Kong",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":443,"conditions":444,"keywords":457,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100284234","fosfomycin-iv-for-treatment-of-severely-infected-patients-100284234","NCT02979951","Fosfomycin I.v. for Treatment of Severely Infected Patients","An International, Multicentre, Non-comparative, Non-interventional, Prospective Clinical Registry to Evaluate the Clinical Outcome and Safety of the Treatment of Severely Infected Patients with Fosfomycin I.v.","FORTRESS","Inclusion Criteria:\n\n* Male or female patients aged ≥ 18 years\n* Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.\n* Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC\n* Written informed consent of the participant (or person in charge in case of patients incapable of giving consent)\n\nExclusion Criteria:\n\n* Previous documentation of the patient in the present study\n* Patients participating in an interventional clinical trial\n* Patients with known hypersensitivity to fosfomycin or any of the excipients\n* Terminally ill patients\n* Patients with \"do not resuscitate order\"\n* Palliative treatment approach\n* Failure of \\> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney\n* Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS)\n* Fosfomycin treatment as 4th line treatment or at later stage\n* Patients with involvement of fungi or mycobacteria in the targeted infection",{"count":54,"type":21},"The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis\u002Fcentral nervous system infection, bacteraemia\u002Fsepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.",[182,445,446,447,448,449,450,128,29,451,452,453,454,424,455,456],"Bone Diseases, Infectious","Osteomyelitis","Central Nervous System Bacterial Infections","Meningitis, Bacterial","Encephalitis","Brain Abscess","Pneumonia, Bacterial","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Bacteremia","Endocarditis, Bacterial",[458,459,460,461,462,463,464,465,466,467,182,468,469,445,446,447,448,449,450,128,29,451,452,453,454,424,455,456,470,471,472,423],"Observational Study","Non-Interventional Study","Registries","Prospective","Monitored","Multicentric","International","Fosfomycin","Infectofos","Fomicyt","Gram-Negative Bacterial Infections","Gram-Positive Bacterial Infections","Treatment Outcome","Clinical Efficacy","Microbiological Efficacy","2024-09-27",{"date":475,"type":37},"2024-10-01",{"date":477,"type":4},"2016-12",{"date":479,"type":21},"2030-12",{"name":481,"class":194},"Infectopharm Arzneimittel GmbH",50,{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":69},"100308768","rapid-analysis-of-infections-by-spectrometry-of-exhaled-breath-100308768","NCT03299608","Rapid Analysis of Infections by Spectrometry of Exhaled Breath","Exhaled Breath Analysis for Rapid Diagnosis in Opportunistic Respiratory Infections in Hematological Patients","RAISE","Inclusion Criteria:\n\n* Age ≥ 18y at start of study\n* One of the following diagnoses:\n\n  * De novo, refractory or relapsed AML\u002FMDS receiving intensive chemotherapy\n  * De novo, refractory or relapsed ALL\u002FT-lymphoblastic lymphoma receiving intensive chemotherapy\n  * Aplastic anemia requiring ATG therapy\n  * Any patient admitted for either autologous hematopoietic stem cell transplantation. Transplantation may not have been performed at time of enrolment.\n  * Any patient admitted with allogeneic hematopoietic stem cell transplantation within the last year, or planned during this admission.\n* Written informed consent obtained from the patient\n\nExclusion Criteria:\n\n* Hematological disease beyond the specified inclusion criteria\n* Signs of active respiratory infection\n* If previously enrolled: incomplete clearance of all signs of respiratory infection (both clinically, microbiologically and radiologically).",{"count":492,"type":21},246,"To quantify the diagnostic, prognostic and therapeutic value of spectrometric analysis of exhaled breath from hematological patients with respiratory infection.",[29,495],"Hematologic Diseases","2024-07-02",{"date":498,"type":37},"2024-07-03",{"date":500,"type":37},"2019-06-21",{"date":502,"type":21},"2025-09",{"name":504,"class":44},"Universitaire Ziekenhuizen KU Leuven",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":174,"sex":16,"minAge":513,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":516,"briefSummary":517,"conditions":518,"keywords":519,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":69},"100497537","phase-4-non-specific-effects-of-a-modified-measles-vaccination-schedule-to-prevent-allergy-and-unrelated-infection-in-children-100497537","NCT05758532","Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children","Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection With Unrelated Pathogens and Allergic Diseases - a Single-centre Phase IV RCT With a Factorial Design","NEMAU","Inclusion Criteria:\n\n1. Informed Consent as documented by signature\n2. 6-month-old children\n3. In overall good health, without any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) and no clinically significant abnormal finding on history and\u002For physical examination\n4. Fully immunised for age according to the Swiss vaccination schedule\n\n   1. with at least 2 doses of DTP-containing vaccine\n   2. the last dose of vaccine received at least 2 weeks prior to enrolment\n\nExclusion Criteria:\n\n1. Contra-indications to MMR, including\n\n   1. immunosuppression (i.e. proven, suspected, or planned)\n   2. allergy to a component of the vaccine\n   3. receipt of a live-attenuated vaccine in the four weeks prior to inclusion\n2. Vaccine refusal\n3. Indication for an early MMR vaccination, including\n\n   1. Measles outbreak\n   2. Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment)\n   3. Travel to a region with a high risk of measles outbreak\n4. Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including\n\n   1. severe eczema\n   2. parental will\n5. Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known\u002Fsuspected non-compliance, substance abuse, etc.\n6. Plan to move out of the country or have prolong absence during the trial\n7. Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised)\n8. Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)","6 Months",{"count":515,"type":21},500,[24],"The goal of this clinical trial is to evaluate the off-target\u002Fnon-specific effects of the measles-mumps-rubella (MMR) vaccine in children.",[29,222,214,213],[520],"Non-specific\u002Foff-target effect of vaccine","2024-05-27",{"date":523,"type":37},"2024-05-29",{"date":525,"type":37},"2023-03-17",{"date":527,"type":21},"2026-12",{"name":529,"class":44},"Laure Pittet, MD-PhD",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":538,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":4},"100543564","molecular-characterization-of-moraxella-catarrhalis-from-pneumonic-children-at-pediatric-assiut-university-hospital-100543564","NCT06357507","Molecular Characterization of Moraxella Catarrhalis From Pneumonic Children at Pediatric Assiut University Hospital","Molecular Characterization of Moraxella Catarrhalis Isolates From Pneumonic Children at Pediatric Assiut University Hospital","Mcatarrhalis","Inclusion Criteria:\n\n* all children with bacterial pneumonia\n\nExclusion Criteria:\n\n* viral pneumonia , tuberculosis and immunocompromised","1 Month",{"count":540,"type":21},90,"moraxella catarrhalis is responsible for respiratory tract infection in children and adults with streptococcus pneumonia and haemophilus influenza.Moraxella catarrhalis is gram negative diplococci, non-motile and non spore bearing bacteria. Until, 1995 it was considered as a non pathogenic respiratory tract flora.This bacteria is an important pathogen and a common cause of both upper and lower respiratory tract infections, pneumonia, sinusitis and conjunctivitis in infants, children and in elderly patients. In adults, M. catarrhalis also causes chronic obstructive pulmonary disease (COPD) and pneumonia. However, it is associated with a number of respiratory infections affecting both children and adults, including laryngitis, bronchitis and pneumonia .",[29],"2024-04-13",{"date":545,"type":37},"2024-04-16",{"date":547,"type":21},"2024-12-01",{"date":549,"type":21},"2027-12-20",{"name":551,"class":44},"Assiut University",{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":4},"100524214","improved-diagnostics-treatment-and-follow-up-of-acute-exacerbation-of-chronic-obstructive-pulmonary-disease-100524214","NCT06105814","Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease","Improved Diagnostics, Treatment and Follow-up of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPEXNOR)","COPEXNOR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admitted to the emergency room with a tentative diagnosis of AECOPD, and at least two of the following criteria, more than the daily variation,\n\n  * Increased dyspnea\n  * Increased cough\n  * Increased sputum production\n  * Need for change in medication due to AECOPD\n* Signed informed consent. Among patients with temporal or permanent reduced ability to consent, close relatives and\u002For family members must be asked and may approve or reject participation on behalf of the patient. In cases where close relatives\u002Ffamily members are not available, study personnel may include patients according to conscious judgment.\n* Patients will be informed about the study and included by dedicated and approved study personnel (study nurses or study doctors), not by the treating health personnel.\n\nExclusion Criteria:\n\n* Pulmonary embolism, segmental or larger\n* Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg\u002Fkg\u002Fmin noradrenaline or equivalent dose of other vasopressor(s)\n* Glasgow Coma Scale score 3\n* Patients not eligible for lower airways sampling within the first 24 hours of admission\n* Palliative situation with life expectancy \\\u003C 1 week",{"count":93,"type":21},[125],"Chronic obstructive pulmonary disease (COPD) is a chronic and often progressive pulmonary disease, where inflammation and recurrent infections are key pathophysiological contibutors in disease progression. Acute exacerbations of COPD (AECOPD) are often treated with antibiotics, even though only about 50% are caused by bacteria, and the evidence for benefit of empiric antibiotic treatment in AECOPD is conflicting. Microbiological sampling is often insufficient in the setting of AECOPD, and there is a lack of biomarkers distinguishing AECOPD caused by bacteria from those not caused by bacteria, leaving the clinician with few tools to guide the use of antibiotics. Overuse of antibiotics is the main driver of antimicrobial resistance (AMR), a major global public health threat, and obtaining the correct microbiological diagnose is important in guiding treatment of AECOPD.\n\nCOPEXNOR seeks to examine which samples give the highest microbiological yield in AECOPD, comparing induced sputum to nasopharyngeal swabs. We will also compare conventional microbiological diagnostics to modern rapid molecular microbiological tests, to evaluate if faster microbiological diagnosis improves antibiotic stewardship. The study aims to define the microbiological etiology causing AECOPD in the Norwegian COPD-population, and examine the lung microbiome over time. COPEXNOR will explore biomarkers in sputum and blood that can be useful for differentiating patients who will benefit from antibiotic treatment from patients who will not.",[564,27,29],"Chronic Obstructive Pulmonary Disease Exacerbation","2023-10-23",{"date":567,"type":37},"2023-10-30",{"date":569,"type":21},"2024-01-01",{"date":571,"type":21},"2030-12-31",{"name":573,"class":44},"Vestre Viken Hospital Trust"]