乌干达和肯尼亚5岁以下儿童重度贫血出院后管理中每月使用双氢青蒿素-哌喹进行疟疾化学预防：一项多中心、双臂、随机、安慰剂对照、优效性试验的研究方案
Malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: study protocol for a multi-centre, two-arm, randomised, placebo-controlled, superiority trial.
作者信息
Kwambai Titus K, Dhabangi Aggrey, Idro Richard, Opoka Robert, Kariuki Simon, Samuels Aaron M, Desai Meghna, van Hensbroek Michael Boele, John Chandy C, Robberstad Bjarne, Wang Duolao, Phiri Kamija, Ter Kuile Feiko O
机构信息
Kenya Medical Research Institute (KEMRI), Centre for Global Health Research (CGHR), PO Box 1578, Kisumu, 40100, Kenya.
Kisumu County Department of Health, Kenya Ministry of Health, Kisumu, Kenya.
出版信息
Trials. 2018 Nov 6;19(1):610. doi: 10.1186/s13063-018-2972-1.
BACKGROUND
Children hospitalised with severe anaemia in malaria endemic areas in Africa are at high risk of readmission or death within 6 months post-discharge. Currently, no strategy specifically addresses this period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly treatment courses of artemether-lumefantrine given at discharge and at 1 and 2 months prevented 30% of all-cause readmissions by 6 months post-discharge. Another efficacy trial is needed before a policy of malaria chemoprevention can be considered for the post-discharge management of severe anaemia in children under 5 years of age living in malaria endemic areas.
OBJECTIVE
We aim to determine if 3 months of PMC with monthly 3-day treatment courses of dihydroartemisinin-piperaquine is safe and superior to a single 3-day treatment course with artemether-lumefantrine provided as part of standard in-hospital care in reducing all-cause readmissions and deaths (composite primary endpoint) by 6 months in the post-discharge management of children less than 5 years of age admitted with severe anaemia of any or undetermined cause.
METHODS/DESIGN: This is a multi-centre, two-arm, placebo-controlled, individually randomised trial in children under 5 years of age recently discharged following management for severe anaemia. Children in both arms will receive standard in-hospital care for severe anaemia and a 3-day course of artemether-lumefantrine at discharge. At 2 weeks after discharge, surviving children will be randomised to receive either 3-day courses of dihydroartemisinin-piperaquine at 2, 6 and 10 weeks or an identical placebo and followed for 26 weeks through passive case detection. The trial will be conducted in hospitals in malaria endemic areas in Kenya and Uganda. The study is designed to detect a 25% reduction in the incidence of all-cause readmissions or death (composite primary outcome) from 1152 to 864 per 1000 child years (power 80%, α = 0.05) and requires 520 children per arm (1040 total children).
RESULTS
Participant recruitment started in May 2016 and is ongoing.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02671175 . Registered on 28 January 2016.
背景
在非洲疟疾流行地区因严重贫血住院的儿童，出院后6个月内再次入院或死亡的风险很高。目前，尚无专门针对这一时期的策略。在马拉维，出院时以及出院后1个月和2个月每月给予蒿甲醚-本芴醇治疗疗程，进行3个月的出院后疟疾化学预防（PMC），可使出院后6个月内所有原因导致的再次入院率降低30%。在考虑对生活在疟疾流行地区的5岁以下儿童严重贫血进行出院后管理时采用疟疾化学预防政策之前，还需要进行另一项疗效试验。
目的
我们旨在确定，对于因任何原因或不明原因的严重贫血而住院的5岁以下儿童，在出院后管理中，3个月的PMC（每月3天双氢青蒿素-哌喹治疗疗程）是否安全，且在降低所有原因导致的再次入院率和死亡率（复合主要终点）方面优于作为标准住院治疗一部分提供的单剂量3天蒿甲醚-本芴醇治疗疗程，随访6个月。
方法/设计：这是一项针对近期因严重贫血接受治疗后出院的5岁以下儿童的多中心、双臂、安慰剂对照、个体随机试验。两组儿童均将接受严重贫血的标准住院治疗，并在出院时接受3天疗程的蒿甲醚-本芴醇治疗。出院后2周，存活的儿童将被随机分组，分别在第2、6和10周接受3天疗程的双氢青蒿素-哌喹治疗或相同的安慰剂治疗，并通过被动病例检测随访26周。该试验将在肯尼亚和乌干达疟疾流行地区的医院进行。该研究旨在检测所有原因导致的再次入院率或死亡率（复合主要结局）的发生率从每1000儿童年中的1152例降至864例，降低25%（检验效能80%，α = 0.05），每组需要520名儿童（共1040名儿童）。
结果
2016年5月开始招募参与者，招募工作正在进行中。
试验注册
ClinicalTrials.gov，NCT02671175。于2016年1月28日注册。
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