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, 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Zinc Supplements
- Placebo Supplements
Treatment groups
Sponsors and collaborators
Harvard School of Public Health (HSPH)
Lead sponsor
Muhimbili University of Health and Allied Sciences
Collaborator