Home Management of Malaria and Pneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home and Community Management of Fevers/Malaria and Pneumonia in Children Under-five: a Cluster Randomised Controlled Trial of an Integrated Approach in a Rural District of Burkina Faso

Conditions
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Malaria, Pneumonia

Intervention / Treatment
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* Other: home/community case management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: nothing at home level<br>No intervention at community level. The study drugs (arthemeter/Lumefantrine and Cotrimoxazole) available at the health facility drug stores level and prescribed exclusively to sick children attending to the health facility for care seeking. No Community Heath Worker /Key Opinion leader (CHWs/KOLs) selected in those clusters | |
| Experimental: Home management of malaria<br>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 | Other: home/community case management<br> <br> |
| Experimental: Home management of malaria and pneumonia<br>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 | Other: home/community case management<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of death in children aged 6 to 59 months | annual crude mortality rate in children aged 0 to 6 months in the different study arms | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impact of home management of malaria and pneumonia on child mortality, home management of malaria and pneumonia