Home Management of Malaria and Pneumonia

Phase 4

Completed

• Conditions: Malaria; Pneumonia
• Interventions: Other: home/community case management

• Registration Number: NCT02151578
• Lead Sponsor: World Health Organization

Brief Summary

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

Detailed Description

An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2012-06
• Study Completion: 2012-09
• Status Verified: 2014-05
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-29
• Last Update Submitted: 2014-05-29
• Study First Posted: 2014-05-30
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11500

Inclusion Criteria

• living in one of the study cluster (villages)
• no story of allergy to any of the study drugs
• history of fever or body temperature >= 38.5°C

Exclusion Criteria

• signs of severity/complications like impaired consciousness, convulsions, fast breathing etc

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home management of malaria	home/community case management	At the community level, the Community health workers/ keay opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc
Home management of malaria and pneumonia	home/community case management	At the community level, the Community health workers/ key opinion leader (HWs/KOLs) trained and equipped to provide the antimalarial drug (arthemeter/Lumefantrine ) or antibiotic (Cotrimoxazole) to any child with fever ("hot body") without any other signs of complications like impaired consciousness, convulsions, etc. The treatment decision making for the CHWs/KOLs based on the algorithm

Primary Outcome Measures

Name	Time	Method
Number of death in children aged 6 to 59 months	12 months	annual crude mortality rate in children aged 0 to 6 months in the different study arms

Secondary Outcome Measures

Name	Time	Method
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level	12 months

Trial Locations

Locations (1)

Groupe de Recherche Action en Sante (GRAS sarl); 🇧🇫 Ouagadougou, Kadiogo, Burkina Faso