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The Impact of Shigellosis and Recommended Treatment in Children

NCT07433426 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • Diarrhea Infectious
  • Shigella
  • Growth & Development

Interventions

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Subhra Chakraborty, PhD, MPH, MSc · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2029-08-31
Completion
2030-08-31

Countries

  • Bangladesh
  • Zambia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07433426 on ClinicalTrials.gov