[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583231":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":38,"locations":44,"responsibleParty":167,"collaborators":169,"id":178,"slug":179,"hasResults":180,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":180,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":12,"studyType":192,"phases":193,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":47,"whyStopped":12,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"PENTA Foundation","NETWORK",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care (control arm).","NO_INTERVENTION","Standard of care treatments will be delivered according to local practice at each hospital. The standard of care for lower respiratory tract infection includes oxygen therapy as needed, bronchodilators, intravenous fluids, in some cases the use of steroids, antibiotics and any treatment for underlying disease.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention arm","EXPERIMENTAL","Remdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation.",[18],"Drug: Remdesivir",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Remdesivir","Remdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric patients hospitalized with COVID-19. Based on previous clinical evidence and preclinical data, to address the unmet medical need for safe and effective RSV therapy, this study is being conducted to investigate remdesivir in infants and children (aged 0 days to \\\u003C2 years) as a potential treatment for RSV infection.",[14],[26],"VEKLURY®",[28,32,35],{"name":29,"affiliation":30,"role":31},"Tim R Cressey","AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Tavitiya Sudjaritruk","Department of Pediatrics, Faculty of Medicine, Chiang Mai University",{"name":36,"affiliation":37,"role":31},"Pablo Rojo","Hospital Materno Infantil 12 de Octubre",[39],{"name":40,"role":41,"phone":42,"phoneExt":12,"email":43},"Federica D'Ambrosio","CONTACT","+39 049 716 9848","federica.dambrosio@pentafoundation.org",[45,64,80,91,106,122,137,152],{"facility":46,"status":47,"city":48,"state":12,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)","RECRUITING","Bangkok","10330","Thailand","TH",{"type":53,"coordinates":54},"Point",[55,56],100.50144,13.75398,{"lat":56,"lon":55},[59,63],{"name":60,"role":41,"phone":61,"phoneExt":12,"email":62},"Napaporn Chantasrisawad","+662-2564930","napaporn.cha@chula.ac.th",{"name":60,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":65,"status":47,"city":66,"state":12,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Nakornping Hospital","Chiang Mai","50180",{"type":53,"coordinates":69},[70,71],98.98468,18.79038,{"lat":71,"lon":70},[74,79],{"name":75,"role":41,"phone":76,"phoneExt":77,"email":78},"Suparat Kanjanavanit","+6653-999000","Ext.0","skanjanavanit@gmail.com",{"name":75,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":81,"status":47,"city":66,"state":12,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Maharaj Nakorn Chiang Mai Hospital","50200",{"type":53,"coordinates":84},[70,71],{"lat":71,"lon":70},[87,90],{"name":33,"role":41,"phone":88,"phoneExt":12,"email":89},"+66053 936 150","tavitiya.s@cmu.ac.th",{"name":33,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":92,"status":47,"city":93,"state":12,"zip":94,"country":50,"countryCode":51,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Chiangrai Prachanukroh Hospital","Chiang Rai","5700",{"type":53,"coordinates":96},[97,98],99.8325,19.90858,{"lat":98,"lon":97},[101,105],{"name":102,"role":41,"phone":103,"phoneExt":12,"email":104},"Suchada Ruenglerdpong","+6653 910 600","suchada.lan.rueng@gmail.com",{"name":102,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":107,"status":108,"city":109,"state":12,"zip":110,"country":50,"countryCode":51,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Khon Kaen Hospital","NOT_YET_RECRUITING","Khon Kaen","40000",{"type":53,"coordinates":112},[113,114],102.833,16.44671,{"lat":114,"lon":113},[117,121],{"name":118,"role":41,"phone":119,"phoneExt":12,"email":120},"Ussanee Srirompotong","+6643 009 900","u.srirompotong@gmail.com",{"name":118,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":123,"status":47,"city":124,"state":12,"zip":125,"country":50,"countryCode":51,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Lampang Hospital","Lampang","52000",{"type":53,"coordinates":127},[128,129],99.49277,18.29232,{"lat":129,"lon":128},[132,136],{"name":133,"role":41,"phone":134,"phoneExt":12,"email":135},"Mallika Rattanawijit","+6654 237 400","mrattana121@gmail.com",{"name":133,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":138,"status":47,"city":139,"state":12,"zip":140,"country":50,"countryCode":51,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Mahasarakham Hospital","Maha Sarakham","44000",{"type":53,"coordinates":142},[143,144],103.30067,16.18483,{"lat":144,"lon":143},[147,151],{"name":148,"role":41,"phone":149,"phoneExt":12,"email":150},"Supawan Papakhee","+6643 723 355","supawan.pa@chula.ac.th",{"name":148,"role":31,"phone":12,"phoneExt":12,"email":12},{"facility":153,"status":108,"city":154,"state":12,"zip":155,"country":50,"countryCode":51,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Samut Sakhon Hospital","Samut Sakhon","74000",{"type":53,"coordinates":157},[158,159],100.27362,13.54753,{"lat":159,"lon":158},[162,166],{"name":163,"role":41,"phone":164,"phoneExt":12,"email":165},"Shalini Sachdev","+6634 429333","shalu.sachdev84@gmail.com",{"name":163,"role":31,"phone":12,"phoneExt":12,"email":12},{"type":168,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[170,173,176],{"name":171,"class":172},"AMS-PHPT Research Collaboration","UNKNOWN",{"name":174,"class":175},"Chiang Mai University","OTHER",{"name":177,"class":175},"Hospital Universitario 12 de Octubre","100583231","phase-2-safety-pharmacokinetics-and-antiviral-activity-of-remdesivir-veklury-in-hospitalized-children-with-rsv-100583231",false,"NCT06873633","Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV","A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.","THAI-CARES RSV","Inclusion Criteria:\n\n* Signed informed consent from parents\u002Fcaregivers\n* Aged 0 to \\\u003C2 years\n* Weighing at least 2.0 kg\n* Onset of RSV associated-symptoms within 1 week of screening\n* Confirmed\\* with RSV infection (by rapid antigen test or RT PCR)\n* Hospitalized children fulfilling at least two of the following three RSV disease severity criteria:\n\n  * Inadequate oral feeding\n  * Inadequate oxygen saturation (peripheral capillary oxygen saturation \\[SpO2\\] \\\u003C95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%)\n  * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \\[subcostal, intercostal, or suprasternal retraction\\], or both)\n\nExclusion Criteria:\n\n* Preterm infants (gestational age at birth less than 37 weeks) who are aged \\\u003C56 days\n* Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)\n* Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \\\u003C24 hours prior to study drug dosing (e.g. ribavirin)\n* ALT or AST \\> 5 × ULN\n* eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \\\u003C1 year based on a creatinine value cut off dependent on chronological age\n* Any major congenital renal anomaly if \\\u003C28 days\n* Apgar score \\\u003C 5 when last recorded if age \\\u003C24 hours\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.\n* On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)\n* Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives","ALL","0 Days","2 Years",{"count":190,"type":191},120,"ESTIMATED","INTERVENTIONAL",[194],"PHASE2","THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.",[197],"Respiratory Syncytial Virus (RSV)",[199,200,201],"respiration disorders","RSV infection","Respiratory Syncytial Virus Hospitalizations","2025-07-18",{"date":204,"type":205},"2025-07-23","ACTUAL",{"date":207,"type":205},"2025-07-16",{"date":209,"type":191},"2027-02",{"name":5,"class":6},8]