Trial of Zinc Supplements for Young Infants With Clinical Severe Infection in Tanzania
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 3,250
- Locations
- 1
- Primary Endpoint
- Death
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 0 Days to 59 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Death
Time Frame: 90 Days
All-cause infant death
Treatment Failure
Time Frame: 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
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
Secondary Outcomes
- Death during initial hospitalization(Randomization to the date of initial hospitalization discharge, assessed up to 90 days)
- Duration of initial hospital stay(Randomization to Day 90)
- Duration of signs of clinical severe infection(Randomization to Day 90)
- Infant length-for-age z-score at Day 15(Day 15)
- Infant length-for-age z-score at Day 90(Day 90)
- Infant weight-for-age z-score at Day 15(Day 15)
- Infant weight-for-age z-score at Day 90(Day 90)
- Infant weight-for-length z-score at Day 15(Day 15)
- Infant weight-for-length z-score at Day 90(Day 90)
- Plasma zinc concentrations at Day 15(Day 15)
- Diarrhea during initial hospital admission(Randomization to the date of initial hospitalization discharge, assessed up to 90 days)
- Rate of vomiting related to regimen dosing(Randomization to Day 15)
- Re-hospitalization(Date of initial hospitalization discharge to Day 90)
- Presence of any sign of possible severe bacterial infection at Day 15(Day 15)
- Presence of any sign of possible severe bacterial infection at Day 90(Day 90)
- Proportion of Children with Diarrhea at Day 15 or Day 90(Day 15 and Day 90)
Investigators
Christopher Robert Sudfeld
Associate Professor of Global Health and Nutrition
Harvard School of Public Health (HSPH)