RecruitingPhase 2NCT07433426

The Impact of Shigellosis and Recommended Treatment in Children


Sponsor

Johns Hopkins Bloomberg School of Public Health

Enrollment

700 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 MonthsMax Age: 59 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Azithromycin and a drug called Placebo for people with diarrhea infectious, growth & development, and other related conditions. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin

Azithromycin will be given as 10 mg/kg body weight once daily for 5 days

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07433426


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