[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-respiratory-infections-aris\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-respiratory-infections-aris":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,40,69,105,134,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100642897","epidemiological-characteristics-and-clinical-burden-of-rsv-infection-in-children-under-24-months-in-ho-chi-minh-city-2026-2028-100642897",false,"NCT07640581","Epidemiological Characteristics and Clinical Burden of RSV Infection in Children Under 24 Months in Ho Chi Minh City (2026-2028)","Assessing the Epidemiological Characteristics and Clinical Burden of Respiratory Syncytial Virus (RSV) Infection in Children Aged 0-24 Months in Primary Healthcare Settings of Ho Chi Minh City, Vietnam (2026 - 2028)","RSV pediatric","Inclusion Criteria:\n\n* Children aged 0 to \\\u003C24 months (i.e., less than two years old).\n* Children presenting with a diagnosis of acute respiratory infection (ARI), defined as an illness with one or more of the following symptoms: cough, rhinorrhea, sore throat, dyspnea (including wheezing, tachypnea, or apnea\u002Fincreased work of breathing), sepsis (for infants aged \\\u003C6 months), and\u002For fever.\n* Children residing in the lowest administrative division (Phường \u002F Xã) in Vietnam that is designated for the specific study site (outpatient clinic or community hospital). As patients live in the same administrative district as the healthcare facility, this will facilitate follow-up and ensure that the study results are representative of the range of severity of ARI presenting to each specific study site.\n* Parent or LAR provides written informed consent for their child's participation.\n\nExclusion Criteria:\n\n* Children whose mothers received a maternal RSV vaccine during pregnancy or who have themselves received RSV-specific monoclonal antibodies (mAbs).\n* Children with a known non-respiratory cause for hospitalization.\n* Children with respiratory symptoms lasting over 14 days.\n* Children hospitalized elsewhere within the preceding 4 days, excluding admission to the Emergency Department.\n* Children already enrolled in another RSV study within the preceding 3 months.","ALL","0 Months","24 Months",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational, multicenter study employing continuous, convenience sampling, stratified by study site and by fortnightly interval, enrolling until the target sample sizes are achieved over the first epidemiological season (2026) and the second epidemiological season (2027). The study population includes children aged 0 to 24 months presenting to the outpatient or inpatient facilities of the study sites with signs and symptoms of acute respiratory infection (ARI). In Vietnam there is no single guideline for diagnosing ARI, but rather there are guidelines specific to clinical conditions such as pharyngitis, rhinitis, tonsilitis, or pneumonia. This study will use an operational definition where ARI is defined as the presence of one or more of the following clinical features: cough, rhinorrhea, sore throat, dyspnea, and \u002F or fever.\n\nRSV testing using nasopharyngeal (NP) swabs will be collected from all eligible children with consent to participate in the study; if a NP swab is not feasible, a mid-turbinate nasal swab will be used. Specimens will be transported to a central laboratory for real-time, reverse transcription-polymerase chain reaction (RT-PCR) testing.\n\nFurthermore, the stored viral transport media from all the RSV-positive samples will be used for whole genome sequencing (WGS) to determine the subgroup (A or B) of the circulating RSV strains and to analyze the genotype.\n\nThe parent or legally acceptable representative (LAR) of pediatric patients will provide information regarding the patient's demography, such as the family's socioeconomic status and household environment (e.g., exposure to tobacco smoke, overcrowding). The children's immunization history and their mothers' immunization history (i.e., vaccines such as influenza and Tdap received during the pregnancy as part of a maternal immunization program) will be established, which is not to estimate vaccine effectiveness but to document the level of vaccine uptake in these populations during the study. Children with maternal RSV vaccination will be excluded.\n\nCrucially, the parent or LAR also will report on the child's complete medical history, including perinatal \u002F pregnancy history, presence of congenital anomaly, previous history of illness, and detailed history and clinical course of the current illness episode. Maternal hypertension and history of immunological factors will not be explored. Data on the medical treatment will be abstracted from the patients' medical records.\n\nOne month after the outpatient clinic visit or hospital discharge, the parent or LAR will be contacted via mobile phone to ascertain the children's current health status and to collect information on the family's direct costs due to the illness.",[26],"Acute Respiratory Infections (ARIs)","RECRUITING","2026-06-06",{"date":30,"type":31},"2026-06-10","ACTUAL",{"date":33,"type":31},"2026-06-04",{"date":35,"type":22},"2028-08-01",{"name":37,"class":38},"Tam Anh Research Institute","OTHER",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100632425","impact-of-a-multiplex-respiratory-pcr-test-on-outcomes-for-patients-presenting-with-respiratory-illness-in-the-urgent-care-setting-a-hybrid-effectiveness-quasi-experimental-trial-100632425","NCT07513519","Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial","Inclusion Criteria:\n\n* Patients older than 1 year\n* Patients presenting with signs and symptoms of acute respiratory illness including but not limited to bronchitis, bronchiolitis, rhinitis, pharyngitis, tonsillitis, and laryngitis\n* First visit for respiratory indication within the study period\n\nExclusion Criteria:\n\n* Patients younger than 1 year\n* Patients for which there is a clinical suspicion of pneumonia (i.e., severe illness on presentation requiring hospitalization or not eligible for urgent care)\n* Patients experiencing symptoms for \\> 10 days\n* Patients with significant respiratory comorbidities, including COPD, emphysema, pulmonary fibrosis, diseases causing chronic respiratory tract inflammation, and other conditions\n* Patients with other significant oropharyngeal or upper respiratory comorbidities or conditions, including but not limited to nasal deformations, peritonsillar abscess\n* Had a previous visit for respiratory indication within the study period","1 Year",{"count":48,"type":22},800,"INTERVENTIONAL",[51],"NA","This research study will use a hybrid effectiveness-implementation type 1 design to assess effectiveness of the Spotfire R\u002FST assay in the urgent care setting. A hybrid effectiveness-implementation type 1 study primarily focuses on the effectiveness of an intervention (e.g., use of Spotfire R\u002FST) but also simultaneously allows for the collection of data on the barriers and facilitators of implementing the Spotfire R\u002FST test in the real-world urgent care setting.",[26],[55,56,57,58],"SPOTFIRE","R\u002FST","BioFire","BioMérieux","2026-03-30",{"date":61,"type":31},"2026-04-07",{"date":63,"type":31},"2025-12-22",{"date":65,"type":22},"2026-04",{"name":58,"class":67},"INDUSTRY",2,{"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":49,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100617152","phase-3-adaptive-platform-trial-of-treatments-for-respiratory-infections-in-community-settings-treatresp-100617152","NCT07314905","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings (TreatResp)","Adaptive Platform Trial of Treatments for Respiratory Infections in Community Settings","TreatResp","Inclusion Criteria:\n\n* 18 years or older\n* A positive test (PCR or RAT) for one of the pathogens included in the trial's domains (influenza A\u002FB, or other future specified respiratory pathogens),\n* Enrolled within 5 days of symptoms onset. However, this window may vary depending on the domain or specific interventions within each domain (for example 72 hours for Baloxavir).\n* At least two symptoms commonly associated with respiratory infections, including:\n\n  * rhinitis\n  * cough\n  * wheezing\n  * sore throat\n  * nasal congestion\n  * shortness of breath\n  * fatigue\n  * rapid breathing\n  * excessive mucus production\n  * loss of smell or taste\n  * hemoptysis\n  * trouble sleeping or insomnia due to breathing difficulties\n  * fever (defined for purposes of this study as \\>37.5°C\u002F 41).\n\nExclusion Criteria:\n\n* Admitted to hospital or in an ED for more than 24 hours\n* Previously randomized to TreatResp within the past 12 months\n* Currently participating in a clinical trial of a therapeutic agent for acute respiratory pathogen infection that is not\u002Fsuspected not compatible with the study therapeutics\n* Already taking a study therapeutic or contraindication to a study therapeutic\n* Inability for participant or caregiver to provide informed consent.\n\nAdditional eligibility criteria will be applied based on the intervention assigned. For instance, if a participant is randomized to an antiviral treatment, they must not have contraindications specific to that antiviral. This ensures that each treatment is evaluated in a population for whom it is most appropriate and safe.\n\nBaloxavir exclusion:\n\n* Has a known or suspected pregnancy\n* Is breastfeeding\n* Is of childbearing potential and is not willing to use a highly effective contraceptive\n* Has advanced chronic kidney disease (CKD stage 3: eGFR ≥30 to \\\u003C60 mL\u002Fmin, and severe renal impairment (eGFR \\\u003C30 ml\u002Fmin, CKD stage 4-5)\n* Has severe hepatic impairment, or requires a live viral vaccine within the next seven days\n* Has a significant impaired immunity (e.g., due to long-term oral steroids, chemotherapy, or an immune disorder)\n* Requires immediate antiviral treatment or hospitalization as per the clinician's judgment\n* Is allergic to trial medications\n* Is scheduled for elective surgery or procedures requiring general anesthesia within the next two weeks\n* Is co-infected with viruses of interest\n* Received a live viral vaccine within the last 14 days","18 Years",{"count":79,"type":22},264,[81],"PHASE3","TreatResp is a double-blind, individually randomized, multi-centre adaptive platform trial. TreatResp aims to establish an adaptive platform trial aimed at evaluating the clinical- and cost-effectiveness, practical challenges, and outcomes of therapeutics for respiratory pathogens in non-hospitalized patients. Participants will be randomized to receive usual care (i.e., supportive care and symptom relief) or a study therapeutic, which will be determined by the TreatResp Therapeutics Committee. The primary outcomes being evaluated is time to recovery.",[84,85,86,26],"Influenza A","Influenza B","SAR-CoV-2",[88,89,84,85,90,91,92,93,94],"COVID-19","SARS-CoV-2","Influenza","Respiratory pathogens","Respiratory infections","Adaptative Platform Trials (APT)","acute respiratory infections (ARIs)","NOT_YET_RECRUITING","2025-12-31",{"date":98,"type":31},"2026-01-02",{"date":98,"type":22},{"date":101,"type":22},"2027-04-24",{"name":103,"class":38},"Unity Health Toronto",1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100609241","febridx-pediatric-validation-study-100609241","NCT07211997","FebriDx® Pediatric Validation Study","FebriDx® Pediatric Validation Study Protocol","Inclusion Criteria:\n\n* Signed informed consent by parent\u002Fguardian and Assent for ages 7-11 years\n* Exhibit or report of a new onset measured temperature (oral or tympanic) of greater than or equal to 100.4°F\u002F38°C within 3 days (72 hours) of enrollment\n* Clinical suspicion for Acute Respiratory Infection beginning within 7 days before enrollment AND presents with at least one of the following new onset of symptoms: runny nose, nasal congestion, sore throat, cough, hoarse voice, shortness of breath \u002F difficulty breathing\n\nExclusion Criteria:\n\n* Unwilling to participate in 7-day follow-up or sign HIPAA waiver to obtain medical record if hospitalized\n* Immunocompromised state or taking immunosuppressive or chemotherapeutic medications in the last 30 days (e.g. oral \u002F inhaled steroids, Methotrexate, Cyclosporine, Chemotherapy, interferon therapy)\n* Taking antibiotics or antiviral therapy in the last 14 days\n* Received a live viral immunization in the last 14 days\n* Clinical diagnosis of otitis media or recognizable viral syndrome (i.e., croup, varicella, stomatitis) at the time of enrollment\n* Prior enrollment in the study","2 Years","11 Years",{"count":48,"type":22},"The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the emergency department, urgent care center or primary care office with a suspected acute respiratory tract infection.",[26],[118,119,120,121,122,123],"Pediatric","Host immune response","Biomarkers","Point-of-Care","Myxovirus resistance protein A (MxA)","C-reactive protein (CRP)","2025-10-30",{"date":126,"type":31},"2025-10-31",{"date":128,"type":31},"2025-10-09",{"date":130,"type":22},"2026-11-30",{"name":132,"class":67},"Lumos Diagnostics",10,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":142,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100598710","rsv-in-acute-respiratory-infection-surveillance-among-community-dwelling-elderly-aged-50-years-in-china-100598710","NCT07075029","RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China","RSV in Acute Respiratory Infection Surveillance Among Community-Dwelling Elderly Aged ≥50 Years in China: A Prospective, Observational, Community-Based Study","RAISE","Inclusion Criteria:\n\n* CRE-ARI group:\n\n  1. Male or female adults aged ≥50 years (calculated based on date of birth and date of visit).\n  2. Presence one of the following conditions of ARI case definition :\n\n     * At least two respiratory symptoms\u002Fsigns within 48 hours prior to self-reporting OR\n     * At least one respiratory symptom\u002Fsign + one systemic symptom\u002Fsign within 48 hours prior to self-reporting\n  3. Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.\n* CAI group:\n\n  1. In the household, include at least one patient meeting the inclusion criteria (index case\\[s\\]) of CRE-ARI group.\n  2. Male or female adults aged ≥50 years or children aged\\\u003C5 years (calculated based on date of birth and date of visit).\n  3. In the household, apart from the index case(s), there are two or more members who meet the criteria (2) AND are willing to participate, regardless of whether these household members exhibit ARI symptoms.\n  4. Provision of written informed consent by the participant or their legal guardian, in accordance with local EC (Ethics Committee) requirements.\n\nExclusion Criteria:\n\n1. Enrollment in the CRE-ARI group within the preceding 14 days.\n2. Enrollment in the CRE-ARI group has been more than 4 times during the previous 12 months (applicable only to the CRE-ARI group enrollment).\n3. For CAI group, if a household has been enrolled into CAI group within the previous 12 months.\n4. Residence outside the designated study catchment area.\n5. Unwilling to provide consent\u002Fassent (if applicable) to participate.\n6. Unwilling to provide biological samples.\n7. Any other situation deemed inappropriate for participation by the investigator, including potential risks to the subject upon enrollment or factors that may affect the interpretation of study results, such as clinical judgment, safety concerns, or the integrity of the study.",true,{"count":144,"type":22},28800,"This is a multicenter, prospective, observational, community-based study designed to evaluate the incidence of respiratory syncytial virus (RSV) infection among community-dwelling elderly individuals in China, as well as their cohabiting older adults and children, over a 24-month period. During the study, home visits will be conducted to collect nasopharyngeal (NP) swabs from all community residents aged ≥50 years who report symptoms of acute respiratory infection (ARI). Pathogen detection will be performed using both point-of-care testing (POCT) and centralized laboratory analysis.",[26],[148,149,150],"RSV","Acute Respiratory Infections","Community","2025-07-10",{"date":153,"type":31},"2025-07-20",{"date":155,"type":22},"2025-09-01",{"date":157,"type":22},"2027-12-31",{"name":159,"class":38},"Huashan Hospital",13,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":49,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":104},"100576075","routine-application-of-point-of-care-pcr-test-to-identify-and-direct-therapy-for-acute-respiratory-infection-in-the-emergency-department-trial-100576075","NCT06780566","Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department Trial","Routine Application of Point-of-care PCR Test to Identify and Direct Therapy for Acute Respiratory Infection in the Emergency Department (RAPID-ARIED) Trial","RAPID-ARIED","Inclusion Criteria:\n\n* Adult patients aged 18 years or above\n* Intended for admission to hospital with acute respiratory illness (defined as a provisional diagnosis of pneumonia, bronchitis, influenza-like illness, acute exacerbation of chronic obstructive pulmonary disease, asthma or bronchiectasis.)\n* Respiratory symptoms present ≤10 days before admission to hospital\n* No prior treatment with antibiotics or antivirals in the previous 14 days\n\nExclusion Criteria:\n\n* Refusal of nasal or pharyngeal swabbing\n* Refusal of informed consent\n* Previously included in the study and re-presentation within 28 days of hospital discharge\n* A prior positive test by antigen test or other PCR test for COVID-19 or influenza before ED presentation\n* Exposure to FluMist® or other similar live attenuated influenza vaccines within 1 month (because such exposures may lead to a false positive PCR test result with the nasal swab sample).",{"count":170,"type":22},1050,[51],"The RAPID-ARIED Trial is a pragmatic, single-centre, parallel group, open-label, randomised controlled trial to be conducted in the Accident and Emergency Department of Queen Mary Hospital in Hong Kong. The investigators aim to 1) to evaluate the clinical impact of the routine application of point-of-care polymerase chain reaction (PCR) testing for targeted respiratory pathogens in the emergency department (ED) for adult patients with acute respiratory infections (ARIs) on the hospital length of stay (LOS), antiviral and antibiotic use during influenza seasons or future waves of COVID-19; and 2) to conduct a health economic analysis of such a strategy.\n\nThe investigators hypothesise that in adult patients hospitalised from the ED for ARIs during influenza seasons or COVID-19 waves, routine point-of-care PCR test for influenza A\\&B, SARS-CoV-2 and respiratory syncytial virus in the ED reduces the hospital LOS significantly and cost effectively compared to usual care.\n\nIn total, 1,050 adult patients who are intended to be admitted to hospital with ARIs in the ED will be recruited during influenza seasons or future waves of COVID-19 over 36 months from 2025 to 2027.\n\nParticipants will be randomised (1:1 ratio) into the interventional group and control group. A nasal swab will be collected. In the intervention group, research staff will perform PCR test using the GeneXpert® Xpress PCR kit in the ED and communicate the test results to the patient and the clinical team. In the control group, all microbiology tests will be determined by the clinical team, with retrospective PCR testing of the nasal swab sample after 28 days.\n\nThe primary outcome is the median hospital LOS. Secondary outcomes include antivirals and antibiotics use and administration time, mortality, and quality-adjusted life year, assessed using the EQ-5D-5L questionnaire.\n\nIntention-to-treat analysis (superiority framework) and cost-effectiveness analysis (from healthcare provider perspective) will be conducted.\n\nStudy results will provide evidence regarding the optimal PCR testing strategy in the future influenza seasons and COVID-19 waves.",[90,88,26],[88,175,176,177,178,179,90],"Acute respiratory infections","Point-of-care testing","Polymerase Chain Reaction","Randomized controlled trial","emergency department","2025-03-24",{"date":182,"type":31},"2025-03-28",{"date":184,"type":22},"2025-04-30",{"date":186,"type":22},"2027-08-31",{"name":188,"class":38},"The University of Hong Kong"]