Grant Abstract: Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in Tanzania

Grant Number: 1R01AI175348-01
PI Name: Sudfeld
Project Title: Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in Tanzania

Abstract: The overall project goal is to investigate zinc supplementation in combination with standard antibiotic therapy as a simple, low-cost, and readily available intervention to improve survival and treatment outcomes for Tanzanian young infants hospitalized with ‘clinical severe infection’ as defined by WHO IMCI criteria. To meet these goals, we propose to conduct a ‘gold standard’ randomized, double-blind, placebo-controlled trial of zinc supplementation in Dar es Salaam, Tanzania. Briefly, we will enroll 3,250 Tanzanian young infants (0-59 days) hospitalized with clinical severe infection in Dar es Salaam, Tanzania. All young infants will receive standard antibiotic treatment and will be randomized to receive a 14-day course of twice-daily oral 5 mg elemental zinc supplements (10 mg per day) or a matching 14- day course of a twice-daily placebo regimen. Participants will be followed-up for 90 days to assess vital status and treatment outcomes. We will also collect biological specimens to evaluate potential mechanisms of action and assess modification of any treatment effect by etiology of infection. The primary outcomes of the trial are i) 90-day all-cause mortality and ii) Treatment failure (composite endpoint of death, a new requirement for life support or need to change to second-line antibiotics). The secondary outcomes of the trial include a) time to cessation of signs and symptoms of clinical severe infection, b) time to hospital discharge, c) risk of re- hospitalization and d) 90-day change in nutritional status as assessed by length-for-age, weight-for-length, and weight-for-age z-scores. Evidence from this randomized trial is urgently needed as low-cost and high-impact innovation to improve young infant survival will be required for Tanzania and other developing countries to reach the child mortality Sustainable Development Goal (SDG) by 2030. PUBLIC HEALTH RELEVANCE: Bacterial infections among young infants, including sepsis, meningitis, pneumonia, and others, continue to have a substantial burden in developing countries and are estimated to cause ~33% of neonatal deaths. The proposed randomized, double-blind, placebo-controlled trial will examine whether zinc supplementation combined with standard antibiotic treatment improves survival and treatment outcomes for Tanzanian young infants 0-59 days with clinical severe infection.

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