MalariaPhase 4HMM/PNCT02151578
Home Management of Malaria and Pneumonia
A Phase 4 study testing home/community case management in people with Malaria and Pneumonia, run by World Health Organization at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- What is being tested?
- home/community case management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,500 participants
- Where
- 1 siteBurkina Faso
- Study dates
- Jan 2009to Sep 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- signs of severity/complications like impaired consciousness, convulsions, fast breathing etc
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Groupe de Recherche Action en Sante (GRAS sarl)
Ouagadougou, Kadiogo
About this study
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
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.
Read the 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.
- Being tested
- home/community case management
- Keywords
- Impact of home management of malaria and pneumonia on child mortality, home management of malaria and pneumonia
- Medical subject headings
- Malaria, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home/community case managementOther
| Study group | Role | What they receive |
|---|---|---|
| nothing at home level | No intervention | 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 | 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 Receives: Other: home/community case management |
| Home management of malaria and pneumonia | Experimental | 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 Receives: Other: home/community case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJan 2009
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- World Health Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiomon B. Sirima, World Health Organization
- Investigators
- Sodiomon Bienvenu SIRIMA, MD, PhD, Principal investigator, Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151578
- Sponsor's protocol ID
- HMMP001
- Other IDs
- A70210
- Acronym
- HMM/P
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33565123
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02151578
- Acronym / sponsor ID
- HMM/P / HMMP001
- Keywords
- Impact of home management of malaria and pneumonia on child mortality, home management of malaria and pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,500 participants (actual)
- Lead sponsor
- World Health OrganizationUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nothing at home level | No intervention | –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 | Other: home/community case managementAt 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 | Experimental | Other: home/community case managementAt 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 |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- signs of severity/complications like impaired consciousness, convulsions, fast breathing etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home/community case management | Other | Home management of malaria, Home management of malaria and pneumonia |
Primary outcome
Number of death in children aged 6 to 59 months
Time frame: 12 months
annual crude mortality rate in children aged 0 to 6 months in the different study arms
1 secondary outcome
- specific mortality preceded by acute febrile illness of children aged 6 to 59 months - severe malaria cases at community level
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- Derived from this study: PubMed 33565123Oliphant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sodiomon Bienvenu SIRIMA, MD, PhD principal investigator
Groupe de Recherche Action en santé (GRAS), 06 BP 10248 Ouagadougou 06, Burkina Faso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing home/community case management in people with Malaria and Pneumonia, run by World Health Organization at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of death in children aged 6 to 59 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02151578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.