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

项目摘要 该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、低成本且容易获得的干预措施，可提高患者的存活率和治疗结果 坦桑尼亚婴幼儿因世卫组织IMCI标准定义的“临床严重感染”而住院。相遇 为了实现这些目标，我们建议进行一项锌的随机、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，我们将招募3,250名坦桑尼亚婴儿(0-59天)因临床严重感染而住院。 坦桑尼亚的达累斯萨拉姆。所有幼儿都将接受标准的抗生素治疗，并将被随机分配到 接受14天的疗程，每天两次口服5毫克的元素锌补充剂(每天10毫克)或匹配的14- 每日两次的安慰剂疗程。参与者将接受为期90天的跟踪，以评估生命状态 和治疗结果。我们还将收集生物样本以评估潜在的作用机制。 并根据感染的病因学评估对任何治疗效果的修改。试验的主要结果是 一)90天全因死亡率和二)治疗失败(死亡的综合终点，对生命的新要求 支持或需要改用二线抗生素)。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)复发的风险 住院和d)90天内营养状况的变化，通过按年龄长短、体重长短和 按年龄计算的体重z分数。 迫切需要来自随机试验的证据作为低成本和高影响的创新来改进 坦桑尼亚和其他发展中国家需要婴儿存活才能达到儿童死亡率。 到2030年可持续发展目标(SDG)。

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.