Standardized data collection for multi-center clinical studies of severe malaria in African children: establishing the SMAC network
Standardized data collection for multi-center clinical studies of severe malaria in African children: establishing the SMAC network
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DOI：
10.1016/j.trstmh.2005.09.021
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发表时间：
2006-07-01
影响因子：
2.2
通讯作者：
Wypij, David
中科院分区：
文献类型：
--
作者：
Taylor, Terrie;Olola, Christopher;Wypij, David
非洲儿童严重疟疾（SMAC）网络的建立是为了开展基于死亡率的试验。尽管恶性疟疾每年导致100多万儿童死亡，但单个中心无法招收足够多的患者，以检测死亡率降低20-30%。我们的目标是量化和描述各种流行病学背景下的严重疟疾，以便我们能够设计具有更精确样本量估计的干预研究。我们使用标准化监测机制收集所有住院的寄生虫儿童的临床、实验室和结局数据。2000年12月至2003年12月期间，在五个地点登记了20333名患者。严重疟疾综合症（脑型疟疾、严重疟疾贫血和酸中毒）在不同地点的发生频率不同，特定综合症的死亡率也不同。旨在降低一种或多种严重疟疾综合征死亡率的干预研究需要3-4年才能在现有网络内完成。这些数据对撒哈拉以南非洲因疟疾住院的儿童的疾病负担提供了更准确的估计。网络需要招募足够的病人进行基于死亡率的研究，并涵盖撒哈拉以南非洲疟疾的流行病学多样性。SMAC是发展这种能力的第一次努力。(C) 2006年皇家热带医学与卫生学会。Elsevier Ltd.出版。版权所有。
The Severe Malaria in African Children (SMAC) network was established to conduct mortality-based trials. Although falciparum malaria kilts more than one million children each year, single centers cannot enroll enough patients to detect reductions of 20-30% in mortality rates. Our aim was to quantify and describe severe malaria across a variety of epidemiological settings so that we could design intervention studies with more precise sample size estimates. We used a standardized surveillance mechanism to capture clinical, laboratory and outcome data on all parasitemic children admitted to hospital. Between December 2000 and December 2003, 20333 patients were enrolled at five sites. The frequency of severe malaria syndromes (cerebral malaria, severe malarial anemia and acidosis) differed between sites, as did the syndrome-specific mortality rates. Intervention studies targeted at reducing mortality in one or a combination of severe malaria syndromes would require 3-4 years to complete within the existing network. These data provide more accurate estimates of the disease burden of children hospitalized for malaria in sub-Saharan Africa. Networks are required to recruit enough patients for mortality-based studies and to encompass the epidemiological diversity of malaria in sub-Saharan Africa. SMAC represents the first effort to develop this capacity. (C) 2006 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.