Evaluation of the performance and feasibility of RLDT in detecting Shigella in a primary healthcare facility of rural Bangladesh.
Sampa Dash, Eva Sultana, Kiely Flynn...
https://pubmed.ncbi.nlm.nih.gov/41415506Actively Recruiting
Phase 2
Age: 6Months - 59Months
All Genders
ID07433426
The Impact of Shigellosis and Recommended Treatment in Children with Non-Dysentery Shigella-Associated Watery Diarrhea
Led by Johns Hopkins Bloomberg School of Public Health · Updated on 2026-03-30
700
Participants Needed
4
Research Sites
52 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
Researchers are evaluating whether treating children with non-dysentery Shigella-associated watery diarrhea (NDSD) with antibiotics improves their clinical outcomes and growth. This study focuses on children aged 6 to 59 months who seek care for diarrhea at hospitals in Bangladesh and Zambia. It is a phase 2B, randomized, double-blind, placebo-controlled study aiming to address if antibiotic treatment benefits this group beyond current World Health Organization guidelines, which recommend antibiotics mainly for dysentery or cholera cases. Participants will be randomly assigned to receive either Azithromycin at a dose of 10 mg/kg once daily for five days or a placebo that looks like the medication but contains no active drug. All children will receive standard rehydration therapy and zinc supplementation as part of routine care. Following treatment, children will be monitored for three months through household visits to track health outcomes and growth. During the study, researchers will assess the time it takes for diarrhea to stop and the time to clear the Shigella infection based on stool tests. They will also measure changes in weight-for-age and length-for-age scores over 90 days to evaluate growth. Data collection includes morbidity monitoring and anthropometric measurements. Safety and adherence to the study protocol will be observed throughout the follow-up period, which lasts about three months after enrollment.
CONDITIONS
Brief Title
The Impact of Shigellosis and Recommended Treatment in Children
Who Can Participate
Age: 6Months - 59Months
All Genders
Eligibility Criteria
You may qualify if you...
- Patients older than 6 months and up to 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 will not qualify if you...
- 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 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, chronic bowel disease, or immune system deficiencies
- Fever over 39°C (102°F) with other complications requiring antibiotic treatment
- Other medical problems that may pose risks or affect study participation as judged by the investigator
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 days
Participants receive either Azithromycin or a placebo once daily for 5 days to treat non-dysentery Shigella-associated watery diarrhea. All children will be rehydrated and receive zinc according to standard care.
1 baseline visit
Follow-up
Duration - 3 months
Participants are followed for 3 months through household visits to collect morbidity and growth data.
Multiple household visits during the 3-month follow-up period
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
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Research Team
S
Subhra Chakraborty, PhD, MPH, MSc
M
Melissa Higdon, MPH
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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Published Research Related To This Trial
Evaluation of a simple, rapid and field-adapted diagnostic assay for enterotoxigenic E. coli and Shigella.
Sean Connor, Mirza Velagic, Xueyan Zhang...
https://pubmed.ncbi.nlm.nih.gov/35130310Field evaluation of a simple and rapid diagnostic test, RLDT to detect Shigella and enterotoxigenic E. coli in Indian children.
Goutam Chowdhury, Debjani Ghosh, Yiyi Zhou...
https://pubmed.ncbi.nlm.nih.gov/38627472Development of a simple, rapid, and sensitive diagnostic assay for enterotoxigenic E. coli and Shigella spp applicable to endemic countries.
Subhra Chakraborty, Sean Connor, Mirza Velagic
https://pubmed.ncbi.nlm.nih.gov/35089927