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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要项目的总体目标是研究锌补充剂与标准抗生素疗法的结合作为一种简单、低成本且易于获得的干预措施，可改善患者的生存和治疗结果坦桑尼亚婴儿因“临床严重感染”而住院，符合世界卫生组织 IMCI 标准的定义。为了实现这些目标，我们建议对锌进行“黄金标准”随机、双盲、安慰剂对照试验坦桑尼亚达累斯萨拉姆的补充品。简而言之，我们将招募 3,250 名因临床严重感染住院的坦桑尼亚小婴儿（0-59 天）坦桑尼亚达累斯萨拉姆所有幼儿都将接受标准抗生素治疗，并将被随机分组。接受为期 14 天的疗程，每日两次口服 5 毫克元素锌补充剂（每天 10 毫克）或配套的 14- 每天两次安慰剂疗法的日疗程将跟踪参与者 90 天以评估生命状态。我们还将收集生物样本来评估潜在的作用机制。并评估感染病因对治疗效果的修改该试验的主要结果是 i) 90 天全因死亡率 ii) 治疗失败（死亡的复合终点，生命的新要求支持或需要更换为二线抗生素）。试验的次要结果包括 a) 时间。临床严重感染的体征和症状停止，b) 出院时间，c) 再次感染的风险住院治疗和 d) 90 天的营养状况变化，通过年龄别身长、身长别体重和年龄别体重 z 分数。迫切需要来自这项随机试验的证据，因为低成本和高影响力的创新可以改善坦桑尼亚和其他发展中国家需要小婴儿存活才能达到儿童死亡率到 2030 年的可持续发展目标 (SDG)。