NCT07433426

The Impact of Shigellosis and Recommended Treatment in Children

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Detailed description

The current World Health Organization (WHO) guidelines for the treatment of diarrhea recommend antibiotics when visible blood is present in the stool and in cases suspected of cholera. Currently, \>50% of Shigella-associated diarrhea cases are non-dysentery or watery diarrhea in nature; thus, would not be treated with antibiotics according to guidelines. Absence of dysentery does not exclude Shigella as a cause of diarrhea and may not indicate a lower risk of death. For particularly vulnerable younger or malnourished children, identification and treatment of Shigella infection might be lifesaving. Consequently, a critical question remains to be answered. Should cases of non-dysentery Shigella associated watery diarrhea (NDSD) be treated with antibiotics? The goal of this study is to determine whether antibiotic treatment of NDSD cases improves clinical outcomes and growth in children. This is a phase 2B, randomized, double-blind, placebo-controlled study. Children aged \>6-59 months with NDSD who are seeking care for diarrhea at the study hospitals in Bangladesh and Zambia will be enrolled and randomized to receive either Azithromycin or a placebo (a look-alike substance that contains no drug). All children will be rehydrated with either oral rehydration solution or intravenous fluids, depending on the degree of dehydration, and will receive zinc in accordance with standard of care. Enrolled children will be followed for three months through household visits to collect morbidity and anthropometry data. Primary Outcomes * Time to Cessation of Diarrhea (TCD) between intervention and placebo * Change of Weight-for-age z-score (∆WAZ) in the 90 days following enrolment between intervention and placebo arms. Secondary Outcomes * Change in linear growth measured as change in length-for-age z score (∆LAZ) in the 90 days following enrolment between the placebo and treatment arms * Time to microbiological cure between the intervention and placebo groups.

Conditions

• Diarrhea Infectious
• Shigella
• Growth & Development

Interventions

Type	Name	Description
DRUG	Azithromycin	Azithromycin will be given as 10 mg/kg body weight once daily for 5 days
DRUG	Placebo	Placebo will be similar in appearance to the intervention but will contain inactive ingredients.

Timeline

• Start date: 2026-03-18
• Primary completion: 2029-08-01
• Completion: 2030-08-01
• First posted: 2026-02-25
• Last updated: 2026-03-30

Locations

4 sites across 2 countries: Bangladesh, Zambia