Actively Recruiting
The Impact of Shigellosis and Recommended Treatment in Children
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-03-30
700
Participants Needed
4
Research Sites
228 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Impact of Shigellosis and Recommended Treatment in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged over 6 months and up to 59 months seeking care at the study hospitals
- Residing within the study catchment area
- Presenting with watery diarrhea and testing positive for Shigella by RLDT
- Willing to be available for sample and data collection during follow-up visits
You will not qualify if you...
- Parent or guardian unable or unwilling to give written informed consent or comply with the study protocol
- Diarrhea started more than 96 hours before enrollment
- Antibiotics for shigellosis, including 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
- Visible blood in stool
- Severe acute malnutrition (below -3 z scores of WHO growth standards)
- History of congenital heart disease, known gastrointestinal abnormalities, or immune system deficiencies
- Fever over 39°C (102°F) with complications requiring antibiotic treatment
- Other medical problems that may increase risk, interfere with study compliance, or affect data quality as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
icddr,b Matlab Hospital
Chāndpur, Bangladesh
Not Yet Recruiting
2
icddr,b Hospital
Dhaka, Bangladesh
Actively Recruiting
3
Matero Level 1 Hospital
Lusaka, Zambia
Not Yet Recruiting
4
Arthur Davidson Children's Hospital
Ndola, Zambia
Not Yet Recruiting
Research Team
S
Subhra Chakraborty, PhD, MPH, MSc
CONTACT
M
Melissa Higdon, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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