RecruitingPhase 3Phase 4ACTRN12617000857303

Enhanced community case management to increase access to pneumonia treatment

Enhanced community case management to increase access to pneumonia treatment in children under 5 years of age in sub-Saharan Africa and South Asia

Sponsor

World Health Organization

Enrollment

4,700 participants

Start Date

Sep 16, 2016

Study Type

Interventional

Conditions

Pneumonia

Summary

Pneumonia is the number one killer of under-five children. Around 90% of pneumonia deaths in children occur in sub-Saharan Africa and South Asia. Efforts are being made to increase access to good quality care at health facilities in many LMICs, but progress is slow, in particular in Sub-Saharan Africa and South Asia. As a complementary strategy, where access to health facilities is low and referral advice is not usually accepted by families, WHO/UNICEF recommend management of pneumonia, diarrhoea and malaria by community-level health workers (CLHWs) through integrated community case management (iCCM) at the community level. The overall goal of the project is to rigorously assess the benefits of an enhanced approach to community case management for pneumonia, contributing to the evidence base for revision of WHO/UNICEF integrated community case management (iCCM) tool and its harmonization with the integrated management of childhood illness (IMCI) tool, and using lessons learned during implementation to help accelerate subsequent program scale-up. The “enhanced” pneumonia component of iCCM is the standard iCCM approach PLUS a) Treatment of chest indrawing pneumonia to children 2-59 months old by CLHWs b) Treatment of fast breathing pneumonia to infants 7-59 days of age by CLHWs c) Use of pulse oximetry to identify hypoxaemic infants and children by CLHWs A cluster randomised open-label non-inferiority trial will be conducted, to enrol young infants 7-59 days of age with fast breathing and children 2-59 months of age with chest indrawing, each in four countries in Africa and Asia. The primary question is whether failure rates of pneumonia treatment with “enhanced” iCCM strategy are non-inferior to failure rates of pneumonia treatment with standard iCCM strategy. The trial will have adequate sample size and power to answer the primary study question in each age group. The trial will (i) compare treatment failures of lower chest indrawing pneumonia in 2-59 months old with oral amoxicillin by CLHWs in community to current management at the health facility and (ii) compare treatment failures rates of fast breathing pneumonia in 7-59 days young infants with oral amoxicillin by CLHWs in community to current management at the health facility/hospital.

Eligibility

Sex: Both males and femalesMin Age: 7 DayssMax Age: 59 Monthss

Plain Language Summary

Simplified for easier understanding

This study is testing whether community health workers can safely treat pneumonia in young children at home or in the community — without needing to go to a hospital. Pneumonia kills more children under five than any other disease, and many deaths happen because families live too far from clinics. This trial is being run in Bangladesh, Ethiopia, India, and Malawi. Community workers would use oral antibiotics and a small device that measures oxygen levels (pulse oximetry) to identify and treat pneumonia cases. You may be eligible if: - Your child is between 7 days and 59 months old - Your child lives in one of the study areas (Bangladesh, Ethiopia, India, or Malawi) - Your child is showing signs of pneumonia (fast breathing or chest indrawing) You may NOT be eligible if: - Your infant is less than 7 days old - Your child has danger signs (very severe illness) that require hospital care - You do not give consent for your child to be enrolled Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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. 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. 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.