Ginsburg Amy Sarah, Mvalo Tisungane, Hwang Jun, Phiri Melda, McCollum Eric D, Maliwichi Madalitso, Schmicker Robert, Phiri Ajib, Lufesi Norman, May Susanne
University of Washington Clinical Trial Center, Building 29, Suite 250, 6200 NE 74th Street, Seattle, WA, 98115, USA.
University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.
Pneumonia (Nathan). 2021 Feb 25;13(1):3. doi: 10.1186/s41479-021-00081-y.
Due to high risk of mortality, children with comorbidities are typically excluded from trials evaluating pneumonia treatment. Understanding heterogeneity of outcomes among children with pneumonia and comorbidities is critical to ensuring appropriate treatment.
We explored whether the percentage of children with fast-breathing pneumonia cured at Day 14 was lower among those with selected comorbidities enrolled in a prospective observational study than among those enrolled in a concurrent randomized controlled trial evaluating treatment with amoxicillin in Lilongwe, Malawi.
Among 79 children with fast-breathing pneumonia in the prospective observational cohort, 57 (72.2%) had HIV infection/exposure, 20 (25.3%) had malaria, 2 (2.5%) had severe acute malnutrition, and 17 (21.5%) had anemia. Treatment failure rate was slightly (not significantly) lower in children with comorbidities (4.1%, 3/73) compared to those without comorbidities (4.5%, 25/552) similarly treated. There was no significant difference in clinical cure rates by Day 14 (95.8% with vs 96.7% without comorbidity).
Children with fast-breathing pneumonia excluded from a concurrent clinical trial due to comorbidities did not fare worse. Children at higher risk whose caregivers seek care early and who receive appropriate risk assessment (e.g., pulse oximetry, hemoglobin, HIV/malaria testing) and treatment, can achieve clinical cure by Day 14.
ClinicalTrials.gov NCT02960919 ; registered November 8, 2016.
由于死亡风险高，患有合并症的儿童通常被排除在评估肺炎治疗的试验之外。了解肺炎合并症儿童的结局异质性对于确保适当治疗至关重要。
我们探讨了在一项前瞻性观察性研究中入选的患有特定合并症的快速呼吸性肺炎儿童在第14天治愈的百分比是否低于在马拉维利隆圭进行的一项评估阿莫西林治疗的同期随机对照试验中入选的儿童。
在前瞻性观察队列中的79名快速呼吸性肺炎儿童中，57名（72.2%）有HIV感染/暴露史，20名（25.3%）有疟疾，2名（2.5%）有严重急性营养不良，17名（21.5%）有贫血。合并症儿童的治疗失败率（4.1%，3/73）略低于（无显著差异）接受类似治疗的无合并症儿童（4.5%，25/552）。到第14天的临床治愈率无显著差异（合并症组为95.8%，无合并症组为96.7%）。
因合并症而被排除在同期临床试验之外的快速呼吸性肺炎儿童预后并不更差。高危儿童若其照料者尽早寻求治疗并接受适当的风险评估（如脉搏血氧测定、血红蛋白、HIV/疟疾检测）及治疗，到第14天可实现临床治愈。
ClinicalTrials.gov NCT02960919；于2016年11月8日注册。
