[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638772":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":17,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":17,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":17,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":17,"overallStatus":72,"whyStopped":17,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Usual Care","Children with cryptosporidium, rotavirus and\u002For adenoviruses 40\u002F41 will receive usual care provided by icddr,b, which includes standard of care, supportive treatment and azithromycin.",[12],"Drug: Azithromycin",{"label":14,"type":15,"description":16,"interventionNames":17},"Standard of Care","NO_INTERVENTION","Children with cryptosporidium, rotavirus, and\u002For adenovirus 40\u002F41 will not receive azithromycin, but will be treated by standard of care and supportive treatment.",null,[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":17},"DRUG","Azithromycin","Antibiotic treatment (azithroymicin) for children with cryptosporidiosis is not currently recommended (supportive therapy only). The proposed modification to this study would involve randomly assigning the Cryptosporidium-positive children to two groups. Supportive treatment would be provided in both groups, but in one group, antibiotic treatment would be withheld. All children would continue to be monitored in accordance with standard protocols, and antibiotic treatment would be provided if deemed clinically necessary.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":17,"email":29},"Mary Young","CONTACT","4348061737","mky4n@virginia.edu",[31],{"facility":32,"status":17,"city":33,"state":17,"zip":17,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Icddr,B","Dhaka","Bangladesh","BD",{"type":37,"coordinates":38},"Point",[39,40],90.40744,23.7104,{"lat":40,"lon":39},[43],{"name":44,"role":27,"phone":45,"phoneExt":17,"email":46},"Rashidul Haque","880-2-9862896","rhaque@icddrb.org",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","William Petri, MD, PhD","Principle Investigator",[52],{"name":53,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","100638772","phase-1-assessing-the-impact-of-unnecessary-antibiotic-treatment-on-the-development-of-appropriate-adaptive-immune-responses-in-malnourished-bangladeshi-infants-100638772",false,"NCT07615842","Assessing the Impact of Unnecessary Antibiotic Treatment on the Development of Appropriate Adaptive Immune Responses in Malnourished Bangladeshi Infants","Inclusion Criteria:\n\n* presenting with diarrheal symptoms\n* age under 1 year\n* enrolled in study NCT02764918\n\nExclusion Criteria:\n\n* unwilling to give blood and stool samples","ALL","6 Months","48 Months",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The investigators are examining the role of circulating T follicular helper (Tfh) cells in the induction of the antibody responses. The investigators hypothesize that Tfh cell activation is impaired in Bangladeshi children and that this activation failure is associated with a history of antibiotic use. The results of the investigators' preliminary studies suggest that antibiotic treatment could have a detrimental effect on the development of an appropriate adaptive immune response against Cryptosporidium. Antibiotic treatment for children with cryptosporidiosis, rotavirus and adenovirus 40\u002F41is not currently recommended (supportive therapy only), although usually given to children in Dhaka, Bangladesh. This study will randomly assign children with diarrhea due to Cryptosporidium, rotavirus or adenovirus 40\u002F41 to two groups. Supportive treatment would be provided in both groups, but in group #1, antibiotic treatment would be withheld while group #2 will receive usual care which normally will include antibiotic treatment. The investigators will monitor the children for one year to measure T follicular helper function, antibody production, and reinfection.",[71],"Antibiotic Resistance Prevention","NOT_YET_RECRUITING","2026-05-29",{"date":75,"type":76},"2026-06-01","ACTUAL",{"date":75,"type":65},{"date":79,"type":65},"2028-06-01",{"name":5,"class":6},1]