Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in Tanzania
Trial of Zinc Supplements for Young Infants with Clinical Severe Infection in Tanzania
批准号:
10635077
负责人:
CHRISTOPHER P DUGGAN
金额:
$64.85万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-02-17 至 2028-01-31
关键词:
Africa South of the SaharaAgeAntibiotic ResistanceAntibiotic TherapyAntibioticsAntimicrobial ResistanceAsiaBacterial InfectionsBiologicalCase Fatality RatesCessation of lifeChestChildChild MortalityChildhoodClinicalClinical ManagementDataDeveloping CountriesDevelopmentEnrollmentEtiologyExposure toGeneticGoalsGrowthGuidelinesHealthHeterogeneityHospitalizationHospitalsIncidenceInfantInfant HealthInfant MortalityInfectionInnovative TherapyInterventionLengthLifeMagnesiumMeningitisMeta-AnalysisModificationMorbidity - disease rateMovementNorthern AfricaNutrient availabilityNutritional statusOralOutcomeParticipantPlacebosPneumoniaPoliciesPopulationProbabilityPublishingRandomizedRandomized, Controlled TrialsRecommendationRegimenReportingRiskSample SizeSepsisSeveritiesSigns and SymptomsSpecimenSustainable DevelopmentTabletsTanzaniaTemperatureTimeTreatment FailureTreatment outcomeVariantVital StatusWeightWorld Health OrganizationZinc SulfateZinc deficiencyZinc supplementationcostdisabilitydouble-blind placebo controlled trialefficacy testinghospital readmissionimprovedinnovationlow and middle-income countriesmortalityneonatal deathneonateprimary outcomerandomized trialsecondary outcomesuccesssurvival outcometreatment effect
中文摘要
项目总结
英文摘要
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.
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