Enhanced community case management to increase access to pneumonia treatment

INTERVENTION: In a cluster randomised controlled trial (RCT), in addition to standard Integrated Community Case Mangement (iCCM), (i) young infants 7 to 59 days of age with fast breathing without hypoxaemia and (ii) children 2‐59 months of age with chest indrawing without hypoxaemia will be managed by Community Level Health Workers (CLHWs) with oral amoxicillin, 90 mg/kg/day divided into two doses. For this study oral dispersible amoxicillin in 250 mg scored tablets will be used for both age groups. The dispersible tablets would have to be dispersed in clean water and in expressed breast milk for exclusively breastfed young infants. The WHO recommends 5 days of amoxicillin for chest indrawing pneumonia. For young infants less than two months 7 days therapy will be used. The trial strategy will enhance the existing standard iCCM, which currently recommends referral to hospital for these children. Access to pneumonia treatment will be increased to many children whose families cannot access treatment at hospitals due to various reasons. The proposed intervention is to train CLHWs and maintain their skills to manage infants with fast breathing and children with chest indrawing. Commodities including dispensible amoxicillin tables 250 mg, pulse oximeters, and ARI timers will be regularly provided. All enrolled children will be followed up for up to two weeks and their outcomes will be documented by independent assessors. Before the commencement of original enrolment, 6‐8 days standard and enhanced iCCM training will be given to CLHWs in control and intervention clusters, respectively. In standard iCCM training group, CLHWs will be trained on current WHO/UNICEF iCCM. In enhanced iCCM training group, CLHWs will be trained to provide treatment with oral amoxicillin either for 7 days in case of young infants <2 months of age with fast breathing (>=60 breaths per minute) or for 5 days in case of children 2‐59 months of age with lower chest indrawing pneumonia. Further, CLHWs will also be trained in pulse oximetry to measure oxygen saturation at the time of enrolment and during subsequent visits. Two day refresher trainings will be provided to all CLHWs every six months during the study period. Training sessions will be conducted by iCCM master trainers at each site. These master trainers have undergone separate trainings under WHO facilitators. CLHWs are based at health posts in Ethiopia in community, village clinics in the community in Malawi, at their homes in India and in community clinics in Bangladesh. All enrolled children are treated at their homes except those who are referred to a hospital as per protocol. CONDITION: Acute respiratory infections Pneumonia PRIMARY OUTCOME: Treatment failure rate within day 1‐6 of enrolment will be the primary outcome. ; ; Definition of treatment failure ; 1. Death at any time within day 1 to day 6 of enrolment (and 7‐14 days as secondary outcome). ; 2. Child hospitalised for any reason or has any indication of hospitalisation on day 6. ; 3. Persistence of fast breathing in young infants 7‐59 days of age or persistence of chest indrawing in children 2‐59 months of age on day 6 of enrolment. ; 4. Development of serious adverse effect of the study antibiotics (anaphylactic reaction, severe diarrhoea, disseminated and severe rash). ; ; SECONDARY OUTCOME: Evaluating the feasibility of using a pulse oximeter by CLHWs. ; ‐ 7‐59 days old infants in intervention or control clusters who develop fast breathing (respiratory rate >60 breaths per min). ‐ 2‐59 month old children infants in intervention or control clusters who develop chest indrawing pneumonia. Pulse oximeters will be provided to all CLHWs in the intervention clusters. They will be trained to assess hypoxaemia in children with pneumonia through standard training and using standard protocols for use and interpretation of pulse oximetry results. Hypoxaemic children will be referred to the hospital for further management including oxygen therapy. In intervention clusters where enhanced iCCM will be provided by CLHWs, feasibility, acceptability and accuracy of pulse oximetry as used by CLHW’s will be assessed. Impact on referral rates will also be compared between intervention and control clusters. The outcomes of all children with signs of pneumonia will be compared between the intervention and control clusters. Outcome will be assessed by independent outcome assessors (nurses) which will be hired and trained to evaluate children on day 6 for primary outcome measure and on day 14 for secondary outcome measure. The total duration of intervention is up to 2 years. ; Outcome will be assessed by independent outcome assessors (nurses) which will be hired and trained to evaluate children on day 6 for primary outcome measure and on day 14 for secondary outcome measure. ; We will use indepth qualitative interviews and structure observations to evaluate the feasibility of using a pulse oximeter by CLHWs. In all intervention clusters CLHWs will use pulse oximeter to measure oxygen saturation in young infants <2 months of age with fast breathing and children 2‐59 months of age with lower chest indrawing. INCLUSION CRITERIA: In selective districts in Bangladesh, Ethiopia, India and Malawi, first level health facilities (with catchment population of 10,000 to 25,000 each) will be randomised either to control or intervention arm. All CLHWs attached to the first level health facility will provide treatmentment to the following children based on intervention status (control or intervention):