Neonatal Infection Clinical Trial
Official title:
Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
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.
Status | Not yet recruiting |
Enrollment | 3250 |
Est. completion date | June 1, 2026 |
Est. primary completion date | June 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Days to 59 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Tanzania | Muhimbili University of Health and Allied Sciences | Dar Es Salaam |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health (HSPH) | Muhimbili University of Health and Allied Sciences |
Tanzania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death | All-cause infant death | 90 Days | |
Primary | Treatment Failure | A composite endpoint of death during initial period of hospitalization, the need for additional respiratory support (either mechanical ventilation, or positive end expiratory pressure support) or the use of vasoactive medicines to support blood pressure or need to change antibiotics during the initial hospitalization | From date of randomization until the date of first documented treatment failure or date of death from any cause during the initial hospitalization, whichever comes first, assessed up to 90 days |
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