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The Impact of Shigellosis and Recommended Treatment in Children
Sponsor: Johns Hopkins Bloomberg School of Public Health
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.
Key Details
Gender
All
Age Range
6 Months - 59 Months
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2026-03-18
Completion Date
2030-08
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Azithromycin
Azithromycin will be given as 10 mg/kg body weight once daily for 5 days
Placebo
Placebo will be similar in appearance to the intervention but will contain inactive ingredients.
Locations (4)
icddr,b Matlab Hospital
Chāndpur, Bangladesh
icddr,b Hospital
Dhaka, Bangladesh
Matero Level 1 Hospital
Lusaka, Zambia
Arthur Davidson Children's Hospital
Ndola, Zambia