Back to resultsHome Management of Malaria and Pneumonia (HMM/P)
Primary Purpose
Malaria, Pneumonia
Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
home/community case management
Sponsored by
About this trial
This is an interventional treatment trial for Malaria focused on measuring Impact of home management of malaria and pneumonia on child mortality, home management of malaria and pneumonia
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
Sites / Locations
- Groupe de Recherche Action en Sante (GRAS sarl)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
nothing at home level
Home management of malaria
Home management of malaria and pneumonia
Arm 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
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02151578
Brief Title
Home Management of Malaria and Pneumonia
Acronym
HMM/P
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
World Health Organization
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Pneumonia
Keywords
Impact of home management of malaria and pneumonia on child mortality, home management of malaria and pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nothing at home level
Arm Type
No Intervention
Arm 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
Arm Title
Home management of malaria
Arm Type
Experimental
Arm 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
Arm Title
Home management of malaria and pneumonia
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
home/community case management
Primary Outcome Measure Information:
Title
Number of death in children aged 6 to 59 months
Description
annual crude mortality rate in children aged 0 to 6 months in the different study arms
Time Frame
12 months
Secondary Outcome Measure Information:
Title
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Adverse events at community level consecutive to the administration of the cotrimoxazole and arthemeter/lumefantrine
Time Frame
7 days after the administration of the drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sodiomon Bienvenu SIRIMA, MD, PhD
Organizational Affiliation
Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe de Recherche Action en Sante (GRAS sarl)
City
Ouagadougou
State/Province
Kadiogo
Country
Burkina Faso
12. IPD Sharing Statement
Citations:
PubMed Identifier
33565123
Citation
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.
Results Reference
derived
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Home Management of Malaria and Pneumonia
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