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Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Suspended to Recruiting
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    v11
  2. Trial status: Recruiting to Suspended Sponsor's reason: Suspension of Funds
    • Site details revised
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Secondary endpoints expanded, about 106 wordsv8
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 15, 2025 to Dec 27, 2024
    • Site details revised
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary and study completion dates: Jun 1, 2026 to Oct 30, 2027v6
  2. Start date: Nov 1, 2024 to Jan 15, 2025v5
  3. Start date: Sep 1, 2024 to Nov 1, 2024v4
  4. Start date: Jun 30, 2024 to Sep 1, 2024v3
  5. Start date: Mar 1, 2024 to Jun 30, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06102044
Lead Sponsor Harvard School of Public Health (HSPH)
Collaborators: Muhimbili University of Health and Allied Sciences
Conditions
(from sponsor)		 Neonatal Infection
Enrollment 3,250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov