Home Management of Malaria and Pneumonia

NCT ID: NCT02151578

Last Updated: 2014-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Malaria; Pneumonia

Keywords

Impact of home management of malaria and pneumonia on child mortality; home management of malaria and pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nothing at home level

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Home management of malaria

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

Group Type: EXPERIMENTAL

home/community case management

Intervention Type: OTHER

Home management of malaria and pneumonia

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

Group Type: EXPERIMENTAL

home/community case management

Intervention Type: OTHER

Interventions

home/community case management

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: lead

Responsible Party

Sodiomon B. Sirima

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sodiomon Bienvenu SIRIMA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso

Locations

Groupe de Recherche Action en Sante (GRAS sarl)

Ouagadougou, Kadiogo, Burkina Faso

Countries

Burkina Faso

References

Oliphant NP, Manda S, Daniels K, Odendaal WA, Besada D, Kinney M, White Johansson E, Doherty T. Integrated community case management of childhood illness in low- and middle-income countries. Cochrane Database Syst Rev. 2021 Feb 10;2(2):CD012882. doi: 10.1002/14651858.CD012882.pub2.

Reference Type: DERIVED

PMID: 33565123 (View on PubMed)

Other Identifiers

A70210

Identifier Type: OTHER

Identifier Source: secondary_id

HMMP001

Identifier Type: -

Identifier Source: org_study_id