Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania

Study Overview
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Brief Summary
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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.

Official Title
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Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania

Conditions
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Neonatal Infection

Intervention / Treatment
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* Dietary Supplement: Zinc Supplements
* Dietary Supplement: Placebo Supplements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 59 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc Supplementation<br>14-day regimen of twice-daily 5 mg elemental zinc supplements to be taken orally or by enteral feeding tube | Dietary Supplement: Zinc Supplements<br>* Dispersible zinc sulfate tablets<br>|
| Placebo Comparator: Placebo<br>14-day regimen of twice-daily oral placebo supplements to be taken orally or by enteral feeding tube | Dietary Supplement: Placebo Supplements<br>* Dispersible placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | All-cause infant death | 90 Days | 
| 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 |