Azithromycin for treating non-bloody Shigella watery diarrhea in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled phase 2b study enrolling children aged 6–59 months with Shigella-positive watery diarrhea at hospitals in Bangladesh and Zambia. Participants are randomized to receive azithromycin or a matched placebo alongside standard rehydration and zinc, and are followed with household visits for three months. Primary outcomes include duration of diarrhea, time to microbiological cure (stool shedding of Shigella), and growth measures such as weight-for-age. Enrollment uses point-of-care RLDT testing and excludes children with bloody stools, recent relevant antibiotic use, or severe acute malnutrition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients \>6 and ≤59 months of age seeking care in the study hospitals
* Patients residing within the study catchment area
* Present with watery diarrhea and positive for Shigella by RLDT
* Willing to be available for sample and data collection during the follow up visits

Exclusion Criteria:

* Inability or unwillingness of a participant's parent/guardian to give written informed consent or comply with study protocol
* Diarrhea started more than 96 hours before enrollment
* Antibiotics related to shigellosis treatment (including the investigational drug azithromycin) taken in the past 5 days
* More than 2 doses of antidiarrheal drugs taken in the past 24 hours
* History of allergy to Azithromycin
* Presence of visible blood in stool
* Children with severe acute malnutrition (below -3z scores of the median WHO growth standards).
* History of congenital heart diseases, known gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease, inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment
* Fever over 39°C (102°F) with other complications that require antibiotic treatment
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Where it's running

• icddr,b Hospital
  Dhaka, Bangladesh Recruiting
• icddr,b Matlab Hospital
  Chāndpur, Bangladesh Not yet recruiting
• Matero Level 1 Hospital
  Lusaka, Zambia Not yet recruiting
• Arthur Davidson Children's Hospital
  Ndola, Zambia Not yet recruiting

Study contacts

• Principal investigator: Subhra Chakraborty, PhD, MPH, MSc — Johns Hopkins Bloomberg School of Public Health
• Study coordinator: Subhra Chakraborty, PhD, MPH, MSc
• Email: schakr11@jhu.edu
• Phone: 410-502-3154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.