An observational study in Malaria, sponsored by Kintampo Health Research Centre, Ghana. Completed at 1 site in Ghana. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2010-04-30.
Sponsored by Kintampo Health Research Centre, Ghana · Observational
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.
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:
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 411 is below the median of 600 across 218 observational studies indexed under Malaria.
Browse Malaria studies →Kintampo Health Research Centre, Ghana is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
A rural population in the middle belt of Ghana
Exclusion criteria:
The main outcome is compliance to artesunate-amodiaquine combination therapy
Time frame: Within first three days after diagnosis of malaria
Reasons for non-compliance
Time frame: Within 28 days after diagnosis of malaria
Participants' perception and acceptance of supervision
Time frame: Within 28 days after diagnosis of malaria
Parasite clearance rates on day 14 and 28
Time frame: Within 28 days after diagnosis of malaria
This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Kintampo Health Research Centre, Ghana