[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pneumonia-bacterial\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pneumonia-bacterial":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,69,101,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100624184","phase-1-a-trial-to-evaluate-the-safety-and-reactogenicity-of-an-investigational-pneumococcal-vaccine-in-toddlers-12-to-15-months-of-age-receiving-a-single-booster-dose-100624184",false,"NCT07406334","A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months of Age Receiving a Single Booster Dose","A Phase 1, Observer-Blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 To 15 Months of Age Receiving a Single Booster Dose","Inclusion Criteria:\n\n1. Participants' parent(s)\u002FLegally acceptable representative \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply with all protocol requirements.\n2. Written or witnessed\u002Fthumb printed informed consent obtained from the participants' parent(s)\u002FLAR(s) prior any study-specific procedure is performed.\n3. A male or female between, and including, 12 to15 Months of age at the time of the study intervention administration.\n4. Healthy participants or medically stable patients as established by medical history and clinical examination before entering the study.\n5. To the best knowledge of the participant's parent(s)\u002FLAR(s), the child has been eligible for pneumococcal vaccination and has completed a 2-dose primary series with PCV10.\n\nExclusion Criteria:\n\n1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n2. Hypersensitivity to latex.\n3. History of microbiologically proven Invasive pneumococcal Disease (IPD).\n4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n5. Major congenital defects, as assessed by the investigator.\n6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.\n7. Condition that in the judgment of the investigator would make intramuscular injection unsafe.\n8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n9. Use of any investigational or non-registered product (drug, vaccine, or invasive medical device) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period.\n10. Previous vaccination with any pneumococcal vaccine other than PCV10.\n11. Previous receipt of more than 2 pneumococcal vaccine doses (primary series or booster).\n12. Planned administration\u002Fadministration of any inactivated or otherwise non-live vaccine in the period starting 14 days before and ending 14 days after the dose of study intervention administration or planned administration\u002Fadministration of any live vaccine in the period starting 28 days before and ending 28 days after the dose of study intervention administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention.\n13. Receipt of blood or plasma products or immunoglobulins, from 90 days before study intervention administration, or planned receipt up to 30 days of study intervention administration.\n14. Chronic administration of immune-modifying drugs and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the study.\n\n    * For corticosteroids: prednisone equivalent ≥0.5 mg\u002Fkg\u002Fday (maximum 20 mg\u002Fday) within 90 days prior for pediatric participants.\n    * Inhaled and topical steroids are allowed.\n15. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.\n16. Any child of trial personnel or their immediate dependents, family, or household members.\n17. Child in care.",true,"ALL","12 Months","15 Months",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The main purpose of this study is to assess the safety and reactogenicity of a single dose of the new pneumococcal vaccine (called Pn-MAPS30plus) in toddlers who have previously completed a two-dose primary vaccination series with PCV used in local immunization program. PCV20 will be used as a comparator for this study.",[28],"Pneumonia, Bacterial",[30,31,32,33],"Pneumococcal Vaccine","Phase 1","Pediatric","Booster dose","NOT_YET_RECRUITING","2026-02-06",{"date":37,"type":38},"2026-02-12","ACTUAL",{"date":40,"type":22},"2026-05-15",{"date":42,"type":22},"2027-02-22",{"name":44,"class":45},"GlaxoSmithKline","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":16,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100624185","phase-1-a-trial-to-evaluate-the-safety-and-reactogenicity-of-an-investigational-pneumococcal-vaccine-in-infants-receiving-3-dose-primary-dosing-series-followed-by-a-booster-dose-at-12-to-15-months-of-age-100624185","NCT07406347","A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age","A Phase 1, Observer-blind, Randomized, Active Controlled Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose Primary Dosing Series Followed by a Booster Dose at 12 to 15 Months of Age","Inclusion Criteria:\n\n1. Participants' parent(s)\u002FLegally acceptable representative \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply with all protocol requirements.\n2. Written or witnessed\u002Fthumb printed informed consent obtained from the participants' parent(s)\u002FLAR(s) prior to performance of any study-specific procedure.\n3. Participant is approximately 2 Months of Age \\[MOA (42 to 90 days, inclusive)\\] at time of first study intervention administration.\n4. Healthy participants as established by medical history and clinical examination before entering the trial.\n5. Participant is a full-term infant (≥37 weeks gestation at birth) with a birth weight of \\>2.5 kg.\n\nExclusion Criteria:\n\n1. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).\n2. Hypersensitivity to latex.\n3. History of microbiologically proven Invasive pneumococcal Disease (IPD).\n4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n5. Major congenital defects, as assessed by the investigator.\n6. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory condition, congenital neurological conditions, encephalopathies, or seizures.\n7. Condition that in the judgment of the investigator would make intramuscular injection unsafe.\n8. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.\n9. Use of any investigational or non-registered product (drug, vaccine, or invasive medical device in the country of enrollment) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the trial period.\n10. Previous vaccination with any pneumococcal vaccine.\n11. Planned administration\u002Fadministration of any inactivated or otherwise non live vaccine in the period starting 14 days before and ending 14 days after each dose of study intervention administration or planned administration\u002Fadministration of any live vaccine in the period starting 28 days before and ending 28 days after each dose of study intervention(s) administration, with the exception of inactivated influenza vaccine which may be administered but must be given at least 7 days before or 15 days after receipt of any study intervention.\n12. Receipt of blood or plasma products or immunoglobulins, since birth, or planned receipt during the trial up to 30 days after last study intervention administration.\n13. Chronic administration of immune-modifying drugs and\u002For planned use of long-acting immune-modifying treatments at any time up to the end of the trial since birth. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg\u002Fkg\u002Fday with maximum of 20 mg\u002Fday. Inhaled and topical steroids are allowed.\n14. Concurrent participation in another clinical study in which the participant has been or will be exposed to an investigational or non-investigational intervention.\n15. Any child of trial personnel or their immediate dependents, family, or household members.\n16. Child in care.","42 Days","90 Days",{"count":56,"type":22},60,[25],"The main purpose of this study is to evaluate safety and reactogenicity of the investigational pneumococcal vaccine (called Pn-MAPS30plus). PCV20 will be used as a comparator for this study",[28],[30,31,32,61,62],"Primary and Booster vaccination","Infants",{"date":37,"type":38},{"date":65,"type":22},"2026-07-10",{"date":67,"type":22},"2028-04-03",{"name":44,"class":45},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100534397","rapid-de-escalation-of-anti-mrsa-therapy-guided-by-s-aureus-nares-screening-in-case-of-pneumonia-100534397","NCT06238297","Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia","Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia (SNAP Study)","SNAP","Inclusion Criteria:\n\n* Subjects 18 years or older.\n* Patients hospitalized at the Azienda Consorziale Policlinico di Bari;\n* Clinical diagnosis of CAP\u002FHAP\u002FVAP;\n* Commitment by the prescribing physician to set an anti-MRSA antibiotic therapy in empirical\n* Enrollement within 48h from the beginning of the empirical anti-MRSA therapy.\n\nExclusion Criteria:\n\n* Febrile neutropenia or severe immunodeficiency;\n* Chronic airway infection (eg cystic fibrosis);\n* Suspect of extrapulmonary infection by MRSA\n* Refusal by the patient or legal guardian;\n* Refusal by the physician in charge of the patient to perform antibiotic de-escalation based on the result of the nasal swab;\n* Enrollment after 48 hours from the beginning of the empirical anti-MRSA therapy.","18 Years",{"count":79,"type":22},76,[81],"NA","The current IDSA\u002FATS guidelines recommend Linezolid and Vancomycin for MRSA coverage in hospitalized patients with pneumonia, which is common clinical practice in Italy. However, a nasal PCR-assay for MRSA has a high negative predictive value and can facilitate rapid antibiotic de-escalation, thereby avoiding unnecessary anti-MRSA treatments. The indiscriminate use of these drugs has contributed to the emergence of resistant S. aureus strains and has led to significant adverse effects, without providing any survival benefits. Additionally, it has increased hospital stays and associated costs. The proposed study aims to use this diagnostic tool to shorten empirical anti-MRSA treatment duration in pneumonia patients, focusing on reducing antimicrobial therapy days while measuring in-hospital mortality, length of stay and adverse drug event incidence.",[28],[85,86,87,88],"MRSA","Antimicrobial stewardship","Randomized trial","Pneumonia","RECRUITING","2025-05-23",{"date":92,"type":38},"2025-05-30",{"date":94,"type":38},"2024-05-06",{"date":96,"type":22},"2025-06-30",{"name":98,"class":99},"University of Bari Aldo Moro","OTHER",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":100},"100560937","antimicrobial-therapeutic-drug-monitoring-during-lung-transplant-perioperative-phase-100560937","NCT06583642","Antimicrobial Therapeutic Drug Monitoring During Lung Transplant Perioperative Phase","Inclusion Criteria:\n\n* Recipient of LUTX\n* Age \\> 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old\n* Already undergone LUTX\n* Documented respiratory colonization in the 12 months preceding LUTX\n* Undergoing any antimicrobial therapy preceding LUTX\n* Documented post-LUTX endobronchial plasma leak requiring high levels of PEEP \\> 15 cmH2O.",{"count":108,"type":22},20,"OBSERVATIONAL","Background: Post-LUTX pneumonia represents a leading cause of death along the first month after LUTX. Donor-derived transmission of pathogenic species occurs up to 25% of recipients receiving a graft with a positive BAL culture, despite in-vitro adequate antimicrobial prophylaxis.\n\nHypothesis: LUTX recipients are either exposed to suboptimal antimicrobial doses or antimicrobial penetration into the lug parenchyma is altered either due to surgery (absence of bronchial anastomoses) or to the hyperinflammatory state.\n\nMethods: LUTX recipients admitted to the intensive care unit at the Fondazione IRCCS Ca' Granda Policlinico Hospital. According to the institutional perioperative prophylaxis protocol and the donor\u002Frecipient ecology the most frequent antimicrobial molecules administered will be: cefepime, vancomycin, and meropenem. Antimicrobial pharmacokinetics will be investigated at three timepoints. Plasma levels of the ongoing antimicrobial molecule will be assessed at ICU admission, on postoperative day 1 and on postoperative day 3. Bronchoalveolar lavage (BAL) samples for the measurement of BAL antimicrobial levels will be collected during the BAL performed for clinical indication on postoperative day 1 and on postoperative day 3.\n\nAbsolute plasma and BAL antimicrobial levels will be assessed. The ratio of BAL to plasma dosage of antimicrobial will be assessed to evaluate antimicrobial penetration within the target tissue. Correlation between both plasma and BAL antimicrobial dosage and recipients' postoperative fluid balance, body weight, vasopressor requirement, renal function will be performed.",[112,28,113],"Lung Transplant Infection","Antibiotic Resistant Strain","2025-05-19",{"date":116,"type":38},"2025-05-22",{"date":118,"type":22},"2025-07-01",{"date":120,"type":22},"2027-03-01",{"name":122,"class":99},"Policlinico Hospital",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":109,"phases":4,"briefSummary":133,"conditions":134,"keywords":150,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"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":132,"type":22},1000,"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.",[135,136,137,138,139,140,141,142,143,28,144,145,146,147,148,149],"Bacterial Infections","Bone Diseases, Infectious","Osteomyelitis","Central Nervous System Bacterial Infections","Meningitis, Bacterial","Encephalitis","Brain Abscess","Urinary Tract Infections","Respiratory Tract Infections","Skin Diseases, Bacterial","Soft Tissue Infections","Intraabdominal Infections","Sepsis","Bacteremia","Endocarditis, Bacterial",[151,152,153,154,155,156,157,158,159,160,135,161,162,136,137,138,139,140,141,142,143,28,144,145,146,147,148,149,163,164,165,166],"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","Safety","2024-09-27",{"date":169,"type":38},"2024-10-01",{"date":171,"type":4},"2016-12",{"date":173,"type":22},"2030-12",{"name":175,"class":45},"Infectopharm Arzneimittel GmbH",50]