[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623890":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":34,"locations":40,"responsibleParty":100,"collaborators":11,"id":102,"slug":11,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":11,"eligibilityCriteria":107,"healthyVolunteers":103,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":11,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":11,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Simcere Pharmaceutical Co., Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIM0916","EXPERIMENTAL",null,[13],"Drug: SIM0916",{"label":15,"type":16,"description":11,"interventionNames":17},"SIM0916 Placebo","PLACEBO_COMPARATOR",[18],"Drug: SIM0916 Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","Dose: 20 mg\u002Fkg TID",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],[27,31],{"name":28,"affiliation":29,"role":30},"hanmin liu","West China Second University Hospital","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":33,"role":30},"lanjuan Li","Shulan (Hangzhou) Hospital",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"zhibiao song","CONTACT","86-13641133681","songzhibiao@simcere.com",[41,58,72,87],{"facility":42,"status":43,"city":44,"state":45,"zip":11,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The First Affiliated Hospital Of Xiamen University","RECRUITING","Xiamen","Fujian","China",{"type":48,"coordinates":49},"Point",[50,51],118.08187,24.47979,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":56,"phoneExt":11,"email":57},"Yungang Yang","86-0592-2137303","xmyyg@sina.com",{"facility":59,"status":43,"city":60,"state":61,"zip":11,"country":46,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hunan Children's Hospital","Changsha","Hunan",{"type":48,"coordinates":63},[64,65],112.97087,28.19874,{"lat":65,"lon":64},[68],{"name":69,"role":37,"phone":11,"phoneExt":70,"email":71},"Yanping Chen","86-0731-853561","hnchengyanping@163.com",{"facility":73,"status":74,"city":75,"state":76,"zip":11,"country":46,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"West China Second University Hospital Sichuan University","NOT_YET_RECRUITING","Chengdu","Sichuan",{"type":48,"coordinates":78},[79,80],104.06667,30.66667,{"lat":80,"lon":79},[83],{"name":84,"role":37,"phone":85,"phoneExt":11,"email":86},"Hanmin Liu","(028) 85503960","Hanmin@vip.163.com",{"facility":88,"status":74,"city":89,"state":90,"zip":11,"country":46,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Shulan(hangzhou)Hospital","Hangzhou","Zhejiang",{"type":48,"coordinates":92},[93,94],120.16142,30.29365,{"lat":94,"lon":93},[97],{"name":32,"role":37,"phone":98,"phoneExt":11,"email":99},"86 571 87236456","ljli@zju.edu.cn",{"type":101,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100623890",false,"NCT07402512","A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children","A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection","Inclusion Criteria:\n\n1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;\n2. Weight ≥ 2.5 kg and ≤ 20 kg;\n3. Positive RSV antigen or nucleic acid test\n4. Duration of illness due to RSV infection ≤ 96 hours;\n5. Presence of tachypnea and wheezing;\n6. Wang Bronchiolitis Score≥ 5;\n7. For subjects aged \\\u003C 12 months, head circumference should be within the normal range corresponding to their age and gender.\n\nExclusion Criteria:\n\n1. Subjects who have received protocol-specified prohibited medications:\n2. Subjects with severe intrapulmonary complications or extrapulmonary complications;\n3. Subjects requiring vasopressors or inotropic agents;\n4. Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;\n5. Subjects with a known history of hypercapnia;\n6. Subjects with chronic or persistent feeding difficulties;\n7. Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;\n8. Subjects with congenital metabolic abnormalities;\n9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;\n10. Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;\n11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;\n12. Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;\n13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;\n14. Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;\n15. Subjects with a history of epilepsy or febrile convulsions;\n16. Subjects with a personal or family history of severe allergies or allergies;\n17. Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;\n18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;\n19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.","ALL","1 Month","36 Months",{"count":112,"type":113},498,"ESTIMATED","INTERVENTIONAL",[116],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection.\n\nA total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg\u002Fkg three times daily for 5 consecutive days (15 doses).",[119],"Respiratory Syncytial Virus Infection","2026-03-29",{"date":122,"type":123},"2026-04-02","ACTUAL",{"date":125,"type":123},"2026-03-11",{"date":127,"type":113},"2027-06-30",{"name":5,"class":6},4]