Management of fast breathing pneumonia in young infants aged 7 to 59 days by community level health workers: protocol for a multi-centre cluster randomized controlled trial

BACKGROUND: WHO does not recommend community-level health workers (CLHWs) using integrated community case management (iCCM) to treat 7–59 days old infants with fast breathing with oral amoxicillin, whereas World Health Organization (WHO) integrated management of childhood illness (IMCI) recommends it. We want to collect evidence to help harmonization of both protocols. METHODS: A cluster, randomized, open-label trial will be conducted in Africa and Asia (Ethiopia, Malawi, Bangladesh and India) using a common protocol with the same study design, inclusion criteria, intervention, comparison, and outcomes to contribute to the overall sample size. This trial will also identify hypoxaemia in young infants with fast breathing. CLHWs will assess infants for fast breathing, which will be confirmed by a study supervisor. Enrolled infants in the intervention clusters will be treated with oral amoxicillin, whereas in the control clusters they will be managed as per existing iCCM protocol. An independent outcome assessor will assess all enrolled infants on days 6 and 14 of enrolment for the study outcomes in both intervention and control clusters. Primary outcome will be clinical treatment failure by day 6. This trial will obtain approval from the WHO and site institutional ethics committees. CONCLUSIONS: If the research shows that CLHWs can effectively and safely treat fast breathing pneumonia in 7–59 days old young infants, it will increase access to pneumonia treatment substantially for infants living in communities with poor access to health facilities. Additionally, this evidence will contribute towards the review of the current iCCM protocol and its harmonization with IMCI protocol. TRIAL REGISTRATION: The trial is registered at AZNCTR International Trial Registry as ACTRN12617000857303.