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Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Neonatal Infection Clinical Trial

Official title:
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

Clinical Trial 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 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, double-blind, placebo-controlled trial of zinc supplementation among young infants 0-59 days with severe clinical infection. The trial will enroll 3,250 Tanzanian infants hospitalized with clinical severe infection as defined by WHO Integrated Management of Childhood Illness (IMCI) guidelines. Enrolled infants will receive standard clinical management including antibiotics and will be randomized to receive either a 14-day course of twice-daily 5 mg elemental zinc (10 mg per day) or a matching placebo regimen.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06102044
Study type Interventional
Source Harvard School of Public Health (HSPH)
Contact Christopher R Sudfeld, ScD
Phone (617) 432-5051
Email csudfeld@hsph.harvard.edu
Status Not yet recruiting
Phase Phase 3
Start date June 30, 2024
Completion date June 1, 2026
View Details
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