A double blind community-based randomized trial of amoxicillin versus placebo for fast breathing pneumonia in children aged 2-59 months in Karachi, Pakistan (RETAPP).
A double blind community-based randomized trial of amoxicillin versus placebo for fast breathing pneumonia in children aged 2-59 months in Karachi, Pakistan (RETAPP).
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DOI：
10.1186/s12879-015-1334-9
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发表时间：
2016-01-13
影响因子：
3.7
通讯作者：
Zaidi AK
中科院分区：
文献类型：
--
作者：
Jehan F;Nisar MI;Kerai S;Brown N;Balouch B;Hyder Z;Ambler G;Ginsburg AS;Zaidi AK
快速呼吸性肺炎的特征是在没有危险体征的情况下呼吸急促，其病因主要是病毒。目前的指南建议在资源有限的情况下对所有患有快速呼吸性肺炎的儿童进行抗生素治疗，假设大多数肺炎是细菌性的。缺乏高质量的临床试验证据来质疑或支持世界卫生组织建议的继续使用抗生素。这是一项在巴基斯坦城市卡拉奇的低收入棚户区进行的随机双盲安慰剂对照非劣效性试验，采用1：1的分配比进行平行分配。2-59个月的儿童呼吸急促，没有任何WHO定义的危险体征，并在初级卫生保健中心寻求治疗，随机接受三天的安慰剂或阿莫西林。从以前的研究，样本量为2430名儿童需要超过28个月的时间。主要结局是两组之间累积治疗失败的差异，定义为基于预设定义的新的临床体征，表明疾病进展或死亡，并在治疗的第0、1、2或3天由两名独立的初级卫生保健医生确认。次要结果包括在第5-14天之间测量的复发。将进行修改后的符合方案分析，比较安慰剂组治疗失败的风险（95%置信区间）与阿莫西林组的风险。这项研究将提供证据来支持或反驳使用抗生素治疗快速呼吸性肺炎，为指南的改变铺平道路。临床试验（NIH）注册NCT 02372461
Fast breathing pneumonia is characterized by tachypnoea in the absence of danger signs and is mostly viral in etiology. Current guidelines recommend antibiotic therapy for all children with fast breathing pneumonia in resource limited settings, presuming that most pneumonia is bacterial. High quality clinical trial evidence to challenge or support the continued use of antibiotics, as recommended by the World Health Organization is lacking. This is a randomized double blinded placebo-controlled non-inferiority trial using parallel assignment with 1:1 allocation ratio, to be conducted in low income squatter settlements of urban Karachi, Pakistan. Children 2–59 months old with fast breathing, without any WHO-defined danger signs and seeking care at the primary health care center are randomized to receive either three days of placebo or amoxicillin. From prior studies, a sample size of 2430 children is required over a period of 28 months. Primary outcome is the difference in cumulative treatment failure between the two groups, defined as a new clinical sign based on preset definitions indicating illness progression or mortality and confirmed by two independent primary health care physicians on day 0, 1, 2 or 3 of therapy. Secondary outcomes include relapse measured between days 5–14. Modified per protocol analysis comparing hazards of treatment failure with 95 % confidence intervals in the placebo arm with hazards in the amoxicillin arm will be done. This study will provide evidence to support or refute the use of antibiotics for fast breathing pneumonia paving a way for guideline change. Clinical Trials (NIH) Register NCT02372461