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Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

RecruitingPhase 3Ages 0 Days - 59 DaysAllHarvard School of Public Health (HSPH)
NCT06102044 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 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
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What it tests

  • Zinc Supplements
  • Placebo Supplements
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Where

1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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