Azithromycin for treating non-bloody Shigella watery diarrhea in children
The Impact of Shigellosis and Recommended Treatment in Children
PHASE2 · Johns Hopkins Bloomberg School of Public Health · NCT07433426
It will test whether giving azithromycin to children 6–59 months with Shigella-positive watery (non-bloody) diarrhea shortens the illness, clears the bacteria faster, and improves growth.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health (other) |
| Locations | 4 sites (Chāndpur and 3 other locations) |
| Trial ID | NCT07433426 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 6–59 months who present with watery (non-bloody) diarrhea, test positive for Shigella by RLDT, live within the study catchment area, and can be followed for three months are the ideal candidates.
Not a fit: Children with visible blood in stool, severe acute malnutrition, recent antibiotics for shigellosis, major congenital heart or gastrointestinal abnormalities, or those outside the 6–59 month age range are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, treating non-dysentery Shigella with azithromycin could shorten diarrheal episodes, reduce bacterial shedding, and improve weight gain and survival in vulnerable young children.
How similar studies have performed: Randomized evidence is limited—WHO currently recommends antibiotics only for bloody diarrhea, so treating non-dysentery Shigella is a relatively untested approach with uncertain prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chāndpur and 3 other locations
- icddr,b Matlab Hospital — Chāndpur, Bangladesh (NOT_YET_RECRUITING)
- icddr,b Hospital — Dhaka, Bangladesh (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diarrhea Infectious, Shigella, Growth & Development, shigella, children, randomized clinical trial, weight for age, growth outcomes