The Impact of Shigellosis and Recommended Treatment in Children
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Diarrhea Infectious, Shigella, Growth & Development
In brief
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.
Key facts
- Study ID
- NCT07433426
- Run by
- Johns Hopkins Bloomberg School of Public Health
- People needed
- 700
- Starts
- 2026-03-18
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-03-30
Who can join
Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- icddr,b Hospital — Dhaka, Bangladesh (enrolling)
- icddr,b Matlab Hospital — Chāndpur, Bangladesh
- Matero Level 1 Hospital — Lusaka, Zambia
- Arthur Davidson Children's Hospital — Ndola, Zambia
Full record on ClinicalTrials.gov
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