NCT06102044 Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
| NCT ID | NCT06102044 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Harvard School of Public Health (HSPH) |
| Condition | Neonatal Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,250 participants |
| Start Date | 2024-12-27 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 3,250 participants in total. It began in 2024-12-27 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Christopher R Sudfeld, ScD
PRINCIPAL INVESTIGATOR
Harvard School of Public Health (HSPH)
Frequently Asked Questions
Who can join the NCT06102044 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 59 Days, studying Neonatal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06102044 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 3,250 participants.
Is NCT06102044 currently recruiting?
Yes, NCT06102044 is actively recruiting participants. Contact the research team at csudfeld@hsph.harvard.edu for enrollment information.
Where is the NCT06102044 trial being conducted?
This trial is being conducted at Dar es Salaam, Tanzania.
Who is sponsoring the NCT06102044 clinical trial?
NCT06102044 is sponsored by Harvard School of Public Health (HSPH). The principal investigator is Christopher R Sudfeld, ScD at Harvard School of Public Health (HSPH). The trial plans to enroll 3,250 participants.