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

在坦桑尼亚对患有临床严重感染的小婴儿进行锌补充剂试验

• 批准号: 10635077
• 负责人: CHRISTOPHER P DUGGAN
• 金额: $ 64.85万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-17 至 2028-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10635077
• 关键词: Africa South of the Sahara; Age; Antibiotic Resistance; Antibiotic Therapy; Antibiotics; Antimicrobial Resistance; Asia; Bacterial Infections; Biological; Case Fatality Rates; Cessation of life; Chest; Child; Child Mortality; Childhood; Clinical; Clinical Management; Data; Developing Countries; Development; Enrollment; Etiology; Exposure to; Genetic; Goals; Growth; Guidelines; Health; Heterogeneity; Hospitalization; Hospitals; Incidence; Infant; Infant Health; Infant Mortality; Infection; Innovative Therapy; Intervention; Length; Life; Magnesium; Meningitis; Meta-Analysis; Modification; Morbidity - disease rate; Movement; Northern Africa; Nutrient availability; Nutritional status; Oral; Outcome; Participant; Placebos; Pneumonia; Policies; Population; Probability; Publishing; Randomized; Randomized, Controlled Trials; Recommendation; Regimen; Reporting; Risk; Sample Size; Sepsis; Severities; Signs and Symptoms; Specimen; Sustainable Development; Tablets; Tanzania; Temperature; Time; Treatment Failure; Treatment outcome; Variant; Vital Status; Weight; World Health Organization; Zinc Sulfate; Zinc deficiency; Zinc supplementation; cost; disability; double-blind placebo controlled trial; efficacy testing; hospital readmission; improved; innovation; low and middle-income countries; mortality; neonatal death; neonate; primary outcome; randomized trial; secondary outcome; success; survival outcome; treatment effect

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.

项目摘要 总体项目目标是与标准抗生素疗法结合研究锌补充 作为一种简单，低成本且随时可用的干预措施，以提高生存率和治疗结果 WHO IMCI标准定义的坦桑尼亚年轻婴儿住院了“临床严重感染”。见面 这些目标，我们建议进行锌的随机，双盲，安慰剂对照试验 坦桑尼亚达累斯萨拉姆的补充。 简而言之，我们将注册3,250名坦桑尼亚年轻婴儿（0-59天），住院，患有临床严重感染 坦桑尼亚的达累斯萨拉姆。所有年轻婴儿将接受标准的抗生素治疗，并将其随机分配给 每天两次口服5 mg元素锌补充剂（每天10毫克）或匹配14-- 每天两次安慰剂方案的日常课程。参与者将进行90天的跟踪，以评估生命状态 和治疗结果。我们还将收集生物标本来评估潜在的作用机理 以及通过感染病因对任何治疗效果的评估修饰。试验的主要结果是 i）90天全因死亡率和ii）治疗失败（复合终点，死亡的新要求 支持或需要更改为二线抗生素）。试验的次要结果包括a）时间 停止临床严重感染的体征和症状，b）出院时间，c） 住院和d）按年龄，重量长度和长度评估的营养状况的90天变化 重量年龄的z得分。 迫切需要该随机试验的证据作为低成本和高影响力的创新来改善 坦桑尼亚和其他发展中国家需要年轻的婴儿生存才能达到儿童死亡率 可持续发展目标（SDG）到2030年。