Home Management of Malaria and Pneumonia (HMM/P)

World Health Organization (WHO)

Status and phase: Completed; Phase 4

Conditions: Malaria; Pneumonia

Treatments: Other: home/community case management

Study type: Interventional

Funder types: Other

Identifiers

NCT02151578

HMMP001

A70210 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11,500 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11,500 participants in 3 patient groups

nothing at home level

No Intervention group

Description:

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

Home management of malaria

Experimental group

Description:

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

Treatment:

Other: home/community case management

Home management of malaria and pneumonia

Experimental group

Description:

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

Treatment:

Other: home/community case management