Ginsburg Amy Sarah, May Susanne, Nkwopara Evangelyn, Ambler Gwen, McCollum Eric D, Mvalo Tisungane, Phiri Ajib, Lufesi Norman
Save the Children, Fairfield, CT, United States.
Department of Biostatistics, University of Washington, Seattle, WA, United States.
JMIR Res Protoc. 2019 Jul 29;8(7):e13377. doi: 10.2196/13377.
Pneumonia is the leading infectious cause of death worldwide among children below 5 years of age. Clinical trials are conducted to determine optimal treatment; however, these trials often exclude children with comorbidities and severe illness.
Given the paucity of data from Africa, African-based research is necessary to establish optimal management of childhood pneumonia in malaria-endemic settings in the region. An expanded evidence base that includes children with pneumonia and other comorbidities, who are at high risk for mortality or have other complications and are therefore typically excluded from childhood pneumonia clinical trials, can contribute to future iterations of the World Health Organization Integrated Management of Childhood Illness guidelines.
The study enrolled 1000 children with pneumonia presenting to the outpatient departments of Kamuzu Central or Bwaila District Hospitals in Lilongwe, Malawi, who were excluded from concurrent randomized controlled clinical trials investigating fast breathing and chest indrawing pneumonia and who met the inclusion criteria for this prospective observational study. Each child received standard care for their illnesses per Malawian guidelines and hospital protocol and was prospectively followed up with scheduled study visits on days 1, 2 (if hospitalized), 6, 14 (in person), and 30 (by phone). Our primary objectives are to describe the clinical outcomes of children who meet the inclusion criteria for this study and to investigate whether the percentages of children cured at day 14 among those with either fast breathing or chest indrawing pneumonia and comorbidities such as severe malaria, anemia, severe acute malnutrition, or HIV are lower than those in children without these comorbidities in the standard care groups in concurrent clinical trials. This study was approved by the Western Institutional Review Board, Malawi College of Medicine Research and Ethics Committee, and the Malawi Pharmacy, Medicines and Poisons Board.
This prospective observational study aimed to assess the clinical outcomes of children aged 2-59 months with both pneumonia and other comorbidities in a malaria-endemic region of Malawi.
The Innovative Treatments in Pneumonia project was funded by the Bill and Melinda Gates Foundation (OPP1105080) in April 2014. Enrollment in this study began in 2016, and the primary results are expected in 2019.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13377.
肺炎是全球5岁以下儿童死亡的主要感染性病因。开展临床试验以确定最佳治疗方案；然而，这些试验通常会排除患有合并症和重症的儿童。
鉴于非洲的数据匮乏，有必要在非洲开展研究，以确定该地区疟疾流行地区儿童肺炎的最佳管理方法。一个扩大的证据基础，包括患有肺炎和其他合并症、有高死亡风险或有其他并发症且因此通常被排除在儿童肺炎临床试验之外的儿童，可为世界卫生组织《儿童疾病综合管理》指南的未来版本提供参考。
该研究纳入了1000名因肺炎到马拉维利隆圭的卡穆祖中央医院或贝拉区医院门诊部就诊的儿童，这些儿童被排除在同时进行的关于呼吸急促和胸凹陷性肺炎的随机对照临床试验之外，且符合这项前瞻性观察性研究的纳入标准。每个儿童均按照马拉维指南和医院规程接受针对其疾病的标准治疗，并在第1天、第2天（如住院）、第6天、第14天（亲自随访）和第30天（通过电话）进行预定的研究随访。我们的主要目标是描述符合本研究纳入标准的儿童的临床结局，并调查在同时进行的临床试验的标准治疗组中，患有呼吸急促或胸凹陷性肺炎以及合并症（如重症疟疾、贫血、重度急性营养不良或艾滋病毒）的儿童在第14天治愈的百分比是否低于无这些合并症的儿童。本研究已获得西方机构审查委员会、马拉维医学院研究与伦理委员会以及马拉维药房、药品和毒物委员会的批准。
这项前瞻性观察性研究旨在评估马拉维疟疾流行地区2至59个月大的患有肺炎和其他合并症的儿童的临床结局。
肺炎创新治疗项目于2014年4月由比尔及梅琳达·盖茨基金会（OPP1105080）资助。本研究于2016年开始招募患者，主要结果预计于2019年得出。
国际注册报告识别码（IRRID）：DERR1-10.2196/13377。
