The Impact of Shigellosis and Recommended Treatment in Children
Recruiting
Phase 2
Interventional Study
Diarrhea Infectious
Shigella
Growth & Development
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months – 59 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 700 (estimated)
- Sponsor
- Johns Hopkins Bloomberg School of Public Health · Other
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About This Trial
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). Enro…
Trial Locations
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Eligibility 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
Exc…
Contacts