The Impact of Shigellosis and Recommended Treatment in Children (TrtNDSD)

March 27, 2026 updated by: Johns Hopkins Bloomberg School of Public Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Subhra Chakraborty, PhD, MPH, MSc
  • Phone Number: 410-502-3154
  • Email: schakr11@jhu.edu

Study Contact Backup

Study Locations

  • Bangladesh
      • Chāndpur, Bangladesh
        • Not yet recruiting
        • icddr,b Matlab Hospital
        • Contact:
        • Sub-Investigator:
          • Eva Sultana, MD
      • Dhaka, Bangladesh
        • Recruiting
        • icddr,b Hospital
        • Contact:
        • Sub-Investigator:
          • Sampa Dash, MD
  • Zambia
      • Lusaka, Zambia
        • Not yet recruiting
        • Matero Level 1 Hospital
        • Contact:
        • Sub-Investigator:
          • chikumbutso Chipeta, MD
      • Ndola, Zambia
        • Not yet recruiting
        • Arthur Davidson Children's Hospital
        • Contact:
          • Sam Miti, BSc HB,MBcHB,MMed,FZCOM-PEDS
          • Phone Number: +260966292508
          • Email: drsammiti@gmail.com
        • Contact:
        • Sub-Investigator:
          • Sam Miti, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azithromycin
Children 6-59 months with non-dysentery shigella diarrhea will be treated with Azithromycin 10 mg/kg once daily for 5 days.
Drug: Azithromycin
Azithromycin will be given as 10 mg/kg body weight once daily for 5 days
Placebo Comparator: Placebo
Children 6-59 months with non-dysentery Shigella diarrhea will receive placebo similar in appearance to the experimental drug once daily for 5 days.
Drug: Placebo
Placebo will be similar in appearance to the intervention but will contain inactive ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to cessation of diarrhea (TCD)
Time Frame: From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)
Diarrhea will be defined as 3 or more liquid or loose stool during a 24 hours period (not calendar day). Two diarrhea episodes will be separated by three diarrhea free days in between. Time to cessation of diarrhea (TCD) will be expressed in hours.
From the time of the administration of Azithromycin or placebo until cessation of the diarrhea episode (approximately up to a month)
Change in weight for age Z score (WAZ)
Time Frame: From enrollment to the 90-day follow up
The change in weight for age Z scores from enrollment to the 90-day follow-up
From enrollment to the 90-day follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to microbiological cure
Time Frame: Enrollment to microbiological cure (up to 3 months)
The interval between the administration of the intervention or placebo and two consecutive Shigella-negative stools by culture or Rapid LAMP-based Diagnostic test (RLDT) - a validated point-of-care diagnostic test.
Enrollment to microbiological cure (up to 3 months)
Change in length for age Z score (LAZ)
Time Frame: From enrollment to 90-day follow-up.
Percentage change and mean difference in LAZ from enrollment to 90-day follow-up between the two arms.
From enrollment to 90-day follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Subhra Chakraborty, PhD, MPH, MSc, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00033101
  • U01AI179562 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Growth & Development

Clinical Trials on Azithromycin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe