Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-59
SponsorHarvard School of Public Health (HSPH)

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

3,250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Harvard School of Public Health (HSPH)

Lead sponsor

Muhimbili University of Health and Allied Sciences

Collaborator