Compliance to Artesunate-Amodiaquine Therapy for Uncomplicated Malaria in Rural Ghana
Summary
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.
Description
Primary objective:
• To determine compliance to artesunate-amodiaquine therapy among patients diagnosed with acute uncomplicated malaria in the Kintampo District Hospital.
Secondary objectives:
1. To determine patients compliance to each of the two drugs (artesunate or amodiaquine )
2. To determine reasons for differential compliance to either of the two drugs (artesunate or amodiaquine).
3. To determine patients perception and acceptance of artesunate-amodiaquine therapy for acute uncomplicated malaria.
4. To determine the effect of compliance of artesunate-amodiaquine therapy on clinical and parasitological improvement in acute uncomplicated malaria.
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:
- Reasons for non-compliance would be determined by response of study participants. Care-takers of children below 18 years will answer on behalf of their children with the child's assent.
- Participants' perception and acceptance of supervision: It would be assessed by responses given by study participants in an indepth interview.
- Parasite clearance rates on day 14 and 28 i.e. the proportion of study participants in each group with P. falciparum parasiteamia at day 14 and 28 determined by blood smear microscopy.
- Clinical cure rates by days 14 and 28 i.e. the proportion of study participants in each group with symptoms of malaria on days 14 and 28 determined by a structured questionnaire at these times.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Malaria
Location
Kintampo Health Research Centre
Brong Ahafo Region
Kintampo
Ghana
Status
Completed
Source
Kintampo Health Research Centre, Ghana
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00873938
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Malaria, Vivax
Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.
Malaria Vaccines
Vaccines made from antigens arising from any of the four strains of Plasmodium which cause malaria in humans, or from P. berghei which causes malaria in rodents.
Plasmodium Vivax
A protozoan parasite that causes vivax malaria (MALARIA, VIVAX). This species is found almost everywhere malaria is endemic and is the only one that has a range extending into the temperate regions.
Malaria, Falciparum
Malaria caused by PLASMODIUM FALCIPARUM. This is the severest form of malaria and is associated with the highest levels of parasites in the blood. This disease is characterized by irregularly recurring febrile paroxysms that in extreme cases occur with acute cerebral, renal, or gastrointestinal manifestations.
Plasmodium Cynomolgi
A protozoan parasite that occurs naturally in the macaque. It is similar to PLASMODIUM VIVAX and produces a type of malaria similar to vivax malaria (MALARIA, VIVAX). This species has been found to give rise to both natural and experimental human infections.
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