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首页> 外文期刊>BMJ Open Respiratory Research >Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi
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Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi

机译：马拉维儿科呼吸性肺炎临床试验中严重不良事件的分析

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Introduction Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2–59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin.Methods Enrolled children with fast breathing for age and a history of cough 14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screening, enrolment and during hospitalisation were evaluated. All SAE reports were reviewed for additional information regarding hospitalisation, course of treatment and outcome.Results In total, 102/1126 (9.0%) enrolled children with fast breathing pneumonia were reported to have a SAE. Seventy-five per cent (n=77) of SAEs were pneumonia-related (p0.01). Children2 years of age represented the greatest proportion (61/77, 79.2%) of those with a pneumonia-related SAE. In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children recovered without sequelae.Discussion In this fast breathing pneumonia clinical trial, SAEs occurred infrequently in both the amoxicillin and placebo groups, and amoxicillin was well tolerated.Trial registration number NCT02760420. https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9.
机译：简介肺炎是儿童的主要传染性杀手。我们进行了一项双盲，随机对照，非劣效性试验，比较了马拉维2–59个月大的HIV阴性儿童中安慰剂与阿莫西林治疗快速呼吸性肺炎的比较。方法：对试验中年龄较大，呼吸道咳嗽<14天或呼吸困难史的儿童入组，对试验过程中发生的严重不良事件（SAE）进行检查，以评估疾病的进展，合并症，肺炎的复发和阿莫西林的副作用。随机分为安慰剂或阿莫西林治疗3天，然后随访14天以追踪临床特征和结果。评估病史，体格检查，实验室结果以及在筛查，入组和住院期间收集的所有胸部X光片。对所有SAE报告进行了审查，以获取有关住院，治疗过程和结果的更多信息。结果据报告，共有102/1126名（9.0％）入选的患有快速呼吸性肺炎的儿童患有SAE。 SAE的百分之七十五（n = 77）与肺炎有关（p <0.01）。在与肺炎相关的SAE患儿中，<2岁的儿童所占比例最大（61/77，79.2％）。在阿莫西林组中，有46种SAE发生，其中5例（10.9％）被确定与研究药物可能有关（4例肠胃炎和1例发烧）。两组均无危及生命的肺炎SAE或死亡，并且在退出研究时，所有儿童均已康复且无后遗症。讨论在这项快速呼吸性肺炎临床试验中，阿莫西林和安慰剂组很少发生SAE，对阿莫西林的耐受性良好。试验注册号为NCT02760420。 https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9。

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