Status:
RECRUITING
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Muhimbili University of Health and Allied Sciences
Conditions:
Neonatal Infection
Eligibility:
All Genders
Up to 59 years
Phase:
PHASE3
Brief Summary
Bacterial infections among young infants, including sepsis, meningitis, and pneumonia, continue to cause a substantial number of deaths globally. Zinc supplementation in combination with standard anti...
Eligibility Criteria
Inclusion
- Young infants aged 0-59 days
- Diagnosis of clinical severe infection (CSI)
- Ability to feed enterally
- Intend to stay in the study area for 90 days
- Provided informed consent
Exclusion
- Prior use of zinc supplements during the current illness
- Receipt of antibiotics for \>24 hours before enrollment
- Diarrhea at enrollment
- Signs suggestive of serious illness/condition that is not clinical severe infection
- Previously enrolled in the trial
- Enrolled in other research study
Key Trial Info
Start Date :
December 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2027
Estimated Enrollment :
3250 Patients enrolled
Trial Details
Trial ID
NCT06102044
Start Date
December 27 2024
End Date
October 30 2027
Last Update
December 12 2025
Active Locations (1)
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1
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania