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NCT05590260
Phase 3Interventional
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
View on ClinicalTrials.gov ↗Timeline
- Start date
- Jan 1, 2023
- Primary completion
- Oct 1, 2025
- Completion date
- Dec 1, 2025
- First posted
- Oct 21, 2022
- Last posted
- Oct 21, 2022
- Enrollment
- 4800
- Arms / groups
- 2 / —
- Source
- AACT · ctgov ingestion
Sponsors
- National Institute of Child Health and Human Development (NICHD)Lead sponsor
- Aga Khan UniversityCollaborator
- Bill and Melinda Gates FoundationCollaborator
- Boston UniversityCollaborator
- Columbia UniversityCollaborator
- Indiana UniversityCollaborator
- Institute of Nutrition of Central America and PanamaCollaborator
- International Center for Diarrheal Disease ResearchCollaborator
- University of KinshasaCollaborator
- Lata Medical Research Foundation, Nagpur, IndiaCollaborator
- Moi UniveristyCollaborator
- RTI InternationalCollaborator
- Thomas Jefferson UniversityCollaborator
- Thomas Jefferson UniversityOverall official - principal investigator
- University of Alabama, BirminghamCollaborator
- University of Colorado, DenverCollaborator
- University of North Carolina at Chapel HillCollaborator
- University of VirginiaCollaborator
- University Teaching Hospital, Lusaka, ZambiaCollaborator
- Thomas Jefferson UniversityOfficial
Drugs studied
Indications studied
CDEK-curated fields only — the ClinicalTrials.gov results mirror (baseline measures, adverse events, participant flow) is a separate, currently-dormant pipeline; see MIGRATION_PLAN.md.