Clinical Trial

The Impact of Shigellosis and Recommended Treatment in Children

Study acronym: TrtNDSD
Recruiting Phase 2
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Summary
The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children. Children with NDSD seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive Azithromycin or placebo (a look-alike substance that contains no drug). Enrolled children will be followed for three months with household visits. The investigators will determine whether antibiotic treatment of NDSD reduces the duration of diarrhea and time to microbiological cure (shedding of Shigella in stool), and whether it improves growth in children compared with the placebo group.
Protocol Amendment History 1 change
critical Recruitment opened 2026-03-31
Trial Details
NCT Number NCT07433426
Lead Sponsor Johns Hopkins Bloomberg School of Public Health
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Diarrhea Infectious, Shigella, Growth & Development
Enrollment 700 participants
Start Date 2026-03-18
Primary Completion 2029-08 (estimated)
Study Completion 2030-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-30