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Sponsors and Collaborators: |
Kintampo Health Research Centre, Ghana London School of Hygiene and Tropical Medicine, United Kingdom |
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Information provided by: | Kintampo Health Research Centre, Ghana |
ClinicalTrials.gov Identifier: | NCT00873938 |
With a change in malaria treatment policy to use combination antimalaria therapy, it is envisaged that compliance to combination therapy would be less than that of monotherapy that was being used for case management in Ghana. This is especially so as amodiaquine is unpopular because of its side-effects and the combination therapy is not a single formulation (fixed dose). Compliance may further be enhanced by community supervision through home visits of combination antimalarial therapy in cases of uncomplicated malaria.
This study would assess compliance to Artesunate-Amodiaquine therapy. It would also assess the effect of compliance to artesunate-amodiaquine therapy on clinical and parasitological cure rates. This study targeting age groups above ten years, would complement a child artesunate -amodiaquine efficacy study being undertaken by the same investigators in children ten years and below at Kintampo District at the same time. The funding for the child study has been approved by the Gates Malaria Partnership. Findings from both studies, involving all age groups would be made available to the National Malaria Control Programme and other stakeholders as practical information that may be beneficial to implementing policy change process from antimalarial monotherapy to a combination therapy.
Condition |
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Malaria |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Enrollment: | 411 |
Study Start Date: | October 2005 |
Study Completion Date: | September 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1-supervised |
2 -unsupervised |
Primary objective:
Secondary objectives:
Study design: The study will be a pragmatic randomized control trial. Patients will be recruited based on an inclusion criteria stated below. Baseline clinical symptoms of malaria and presence of malaria parasite (Plasmodium falciparum) in the blood of eligible patients reporting sick at the health facility would be determined. Study patients would be randomized into one of two groups, intervention and control groups.
Intervention:
The intervention refers to supervisory home visits by a trained community volunteer to ensure that paticipants comply to treatment during the artesunate-amodiaquine therapy. Supervisory home visits by a trained community volunteer form a major component of the Community Health Planning and Services programme being implemented by the Ghana Health Service. The intervention group would be supervised during artesunate-amodiaquine therapy and the control group would not be supervised during artesunate-amodiaquine therapy. The primary and secondary outcome measures below will be determined and compared among the intervention and control group
Primary outcome measure:
The main outcome is compliance to artesunate-amodiaquine combination therapy. It is defined as no artesunate or amodiaquine left on the fourth day after start of treatment of a malaria episode. This would be assessed by the investigators direct observation of the blister package of artesunate-Amodiaquine tablets.
Secondary outcome measures:
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
A rural population in the middle belt of Ghana
Inclusion criteria:
Exclusion criteria:
Ghana, Kintampo | |
Kintampo Health Research Centre | |
Brong Ahafo Region, Kintampo, Ghana |
Principal Investigator: | Seth Owusu-Agyei, PhD | Kintampo Health Research Centre, Ghana |
Principal Investigator: | Kwaku P Asante, MD, MPH | Kintampo Health Research Centre, Ghana |
Responsible Party: | Kintampo Health Research Centre ( Kwaku Poku Asante ) |
Study ID Numbers: | 2004/GD/70 |
Study First Received: | March 31, 2009 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00873938 History of Changes |
Health Authority: | Ghana: Ghana-Netherlands Health Research Programme (Sponsors); Ghana: Ghana Health Service Ethical Review Committee |
Artesunate-Amodiaquine Compliance Malaria |
Artesunate Protozoan Infections Amodiaquine Parasitic Diseases Malaria |
Protozoan Infections Coccidiosis Parasitic Diseases Malaria |