Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
Recruiting
Phase 3
Interventional Study
Neonatal Infection
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 Days – 59 Days
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 3,250 (estimated)
- Sponsor
- Harvard School of Public Health (HSPH) · Other
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About This Trial
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 antibiotic therapy may represent a new intervention to reduce mortality and improve treatment outcomes for young infants with clinical severe infection.
The Investigators will conduct a randomized, doubl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Prior use of zinc supplements during the current illness
* Receipt of anti…
Contacts