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Principal Investigator: CHRISTOPHER P DUGGAN
Organization: HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
Fiscal Year: 2024
Award: $602,533
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary
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.
Terms: <0-11 years old><Africa South of the Sahara><Age><Antibiotic Agents><Antibiotic Drugs><Antibiotic Resistance><Antibiotic Therapy><Antibiotic Treatment><Antibiotics><Antimicrobial Resistance><Asia><Bacterial Infections><Biological><Case Fatality Rates><Causality><Cessation of life><Chest><Child><Child Mortality><Child Youth><Childhood><Children (0-21)><Clinical><Clinical Management><Data><Death><Developing Countries><Developing Nations><Development><Diagnostic Findings><Enrollment><Etiology><Exposure to><Generalized Growth><Genetic><Goals><Growth><Guidelines><Health><Heterogeneity><Hospital Admission><Hospitalization><Hospitals><Incidence><Infant><Infant Health><Infant Mortality><Infant Mortality Total><Infection><Innovative Therapy><Intervention><Intervention Strategies><LMIC><Length><Less-Developed Countries><Less-Developed Nations><Life><Magnesium><Meningitis><Meta-Analysis><Mg element><Miscellaneous Antibiotic><Modification><Morbidity><Morbidity - disease rate><Movement><Neonatal Mortality><North Africa><Northern Africa><Nutrient availability><Nutritional status><Oral><Outcome><Participant><Placebos><Pneumonia><Policies><Population><Probability><Publishing><Randomization trial><Randomized><Randomized, Controlled Trials><Recommendation><Regimen><Reporting><Research Specimen><Resistance to antibiotics><Resistant to antibiotics><Risk><Sample Size><Sepsis><Severities><Sham Treatment><Signs and Symptoms><Specimen><Sub-Saharan Africa><Subsaharan Africa><Supplementation with zinc><Sustainable Development><Tablets><Tanzania><Temperature><Third-World Countries><Third-World Nations><Thorace><Thoracic><Thorax><Time><Tissue Growth><Treatment Failure><Treatment outcome><Under-Developed Countries><Under-Developed Nations><Variant><Variation><Vital Status><Weight><World Health Organization><Zinc Sulfate><Zinc decreased><Zinc deficiency><Zinc low><Zinc supplementation><Zn deficiency><Zn levels low><Zn supplementation><Zn++ low><ages><anti-microbial resistant><antibiotic drug resistance><antibiotic resistant><bacteria infection><bacterial disease><bacterial disease treatment><bacterial infectious disease treatment><biologic><blood infection><bloodstream infection><body movement><causation><cost><death among infants><death among neonates><death among newborns><death in first year of life><death in infancy><death in infants><death in neonates><death in newborn><developing country><developing nation><developmental><disability><disease causation><double-blind placebo control trial><double-blind placebo controlled trial><double-masked controlled trial><efficacy testing><enroll><hospital re-admission><hospital readmission><improved><infant death><infant demise><infantile death><innovate><innovation><innovative><interventional strategy><kids><low Zinc level><low and middle-income countries><mortality><mortality among neonates><mortality among newborns><mortality in infants><mortality in neonates><mortality in newborns><neonatal death><neonatal demise><neonate><newborn death><newborn mortality><ontogeny><pediatric><primary outcome><randomisation><randomization><randomized control trial><randomized trial><randomly assigned><re-admission><re-hospitalization><readmission><rehospitalization><resistance to anti-microbial><resistant to antimicrobial><secondary outcome><sham therapy><success><survival outcome><therapy failure><treatment effect><weights><youngster><zinc supplement>