drugset / Trial / NCT02878031

Community Case Management of Chest Indrawing Pneumonia

NCT02878031 ↗

NaSingle-groupOpen-labelTreatment

Summary

This one-arm safety intervention study is aimed at increasing access to treatment of pneumonia by training CHWs, locally referred to as Community Oriented Resource Persons (CORPs), to manage chest indrawing pneumonia using oral amoxicillin, conducting follow-ups and recording their findings in case report forms. CORPs will also be involved in improving care seeking for pneumonia in children by training them to conduct health education sessions for men and women in their respective communities. The primary objective is to assess if CORPs can safely and appropriately manage chest indrawing pneumonia in 2-59 month old children, and refer children with danger signs. The primary outcomes will be the proportion of children under five with chest indrawing pneumonia who were managed appropriately by CORPs and the clinical treatment failure of chest indrawing pneumonia. Secondary outcomes will include proportion of children with chest indrawing followed up by CORPs on day 3 and caregiver adherence to treatment for CI, and clinical relapse of pneumonia between day 7 to 14 among children whose signs of pneumonia disappeared by day 6. Approximately 308 children 2-59 months of age with chest indrawing pneumonia would be needed for this safety intervention study.

Timeline

Start
2016-10
Primary completion
2018-05-30
Completion
2018-08-31

Outcome

Met primary endpoint

paper Cluster-adjusted treatment failure rates by day 6 were significantly reduced in the intervention clusters PMID 22078721 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 250 mg Oral
Subject Amoxicillin Other / unclassified 500 mg Oral
Subject Amoxicillin Other / unclassified 750 mg Oral

Indications