BMJ Glob Health. 2022 Jan;7(1). doi: 10.1136/bmjgh-2021-006405.
The WHO recommends oral amoxicillin for 2-59-month-old children with chest-indrawing pneumonia presenting at the health facility. Community-level health workers (CLHWs) are not allowed to treat these children when presented at the community level. This study aimed to evaluate whether CLHWs can safely and effectively treat children 2-59 months-old with chest indrawing with a 5-day course of oral amoxicillin in a few selected countries in Africa and Asia, especially when a referral is not feasible.
We conducted a prospective multicountry cluster-randomised, open-label, non-inferiority trial in rural areas of four countries (Bangladesh, Ethiopia, India and Malawi) from September 2016 to December 2018. Children aged 2-59 months having parents/caregivers reported cough and/or difficult breathing presenting to a CLHW were screened for enrolment. CLHWs in the intervention clusters assessed children for hypoxaemia and treated non-hypoxaemic chest-indrawing pneumonia with two times per day oral amoxicillin (50 mg/kg body weight per dose) for 5 days at the community level. CLHWs in the control clusters identified chest indrawing and referred them to a referral-level health facility for treatment. Study supervisors performed pulse oximetry in the control clusters except in Bangladesh. Children were assessed for the primary outcome (clinical treatment failure) up to day 14 after enrolment. The accuracy and impact of pulse oximetry by CLHWs in the intervention clusters were also assessed.
In 208 clusters, 1688 CLHWs assessed 62 363 children with cough and/or difficulty breathing. Of these, 4013 non-hypoxaemic 2-59-month-old children with chest-indrawing pneumonia were enrolled. We excluded 116 children from analysis, leaving 3897 for intention-to-treat analysis. In the intervention clusters, 4.3% (90/2081) failed treatment, including five deaths, while in the control clusters, 4.4% (79/1816) failed treatment, including five deaths. The adjusted risk difference was -0.01 (95% CI -1.5% to 1.5%), which satisfied the prespecified non-inferiority criterion. CLHWs correctly performed pulse oximetry in 91.1% (2001/2196) of cases in the intervention clusters.
The community treatment of non-hypoxaemic children with chest-indrawing pneumonia with 5-day oral amoxicillin by trained, equipped and supervised CLHWs is non-inferior to currently recommended facility-based treatment. These findings encourage a review of the existing strategy of community-based management of pneumonia.
ACTRN12617000857303; The Australian New Zealand Clinical Trials Registry.
世界卫生组织建议对在医疗机构就诊的 2-59 月龄有胸凹陷表现的肺炎患儿使用口服阿莫西林进行治疗。不允许社区卫生工作者（CLHW）在社区层面为这些儿童进行治疗。本研究旨在评估 CLHW 是否可以安全有效地治疗在几个选定的非洲和亚洲国家 2-59 月龄有胸凹陷的儿童，使用 5 天疗程的口服阿莫西林治疗，特别是在无法转介的情况下。
我们于 2016 年 9 月至 2018 年 12 月在孟加拉国、埃塞俄比亚、印度和马拉维四个国家的农村地区进行了一项前瞻性多国集群随机、开放标签、非劣效性试验。有父母/照顾者报告咳嗽和/或呼吸困难的 2-59 月龄儿童向 CLHW 就诊时进行了登记筛查。干预组中的 CLHW 评估了非低氧血症性胸凹陷性肺炎患儿的低氧血症，并在社区层面以每日两次的口服阿莫西林（每次 50mg/kg 体重）治疗 5 天。对照组中的 CLHW 识别出胸凹陷并将其转介到转诊级别的卫生机构进行治疗。对照组的研究主管除孟加拉国外，均进行了脉搏血氧饱和度测量。在登记后 14 天内评估儿童的主要结局（临床治疗失败）。还评估了干预组中 CLHW 进行脉搏血氧饱和度测量的准确性和影响。
在 208 个集群中，有 1688 名 CLHW 评估了 62363 名有咳嗽和/或呼吸困难的儿童。其中，有 4013 名非低氧血症性 2-59 月龄有胸凹陷性肺炎患儿被纳入。我们排除了 116 名儿童进行分析，留下 3897 名儿童进行意向治疗分析。在干预组中，有 4.3%（90/2081）治疗失败，包括 5 例死亡，而在对照组中，有 4.4%（79/1816）治疗失败，包括 5 例死亡。调整后的风险差异为-0.01（95%CI-1.5%至 1.5%），符合预先规定的非劣效性标准。干预组中，CLHW 正确进行脉搏血氧饱和度测量的比例为 91.1%（2001/2196）。
经培训、配备和监督的 CLHW 在社区层面为非低氧血症性胸凹陷性肺炎儿童使用 5 天疗程的口服阿莫西林治疗，与目前推荐的医疗机构治疗相比非劣效。这些发现鼓励对现有的基于社区的肺炎管理策略进行审查。
ACTRN12617000857303；澳大利亚和新西兰临床试验注册中心。
