Compliance to Artesunate-Amodiaquine Therapy for Uncomplicated Malaria in Rural Ghana
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 411
- Locations
- 1
- Primary Endpoint
- The main outcome is compliance to artesunate-amodiaquine combination therapy
Study Overview
Brief 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.
Detailed Description
Primary objective:
• To determine compliance to artesunate-amodiaquine therapy among patients diagnosed with acute uncomplicated malaria in the Kintampo District Hospital.
Secondary objectives:
- To determine patients compliance to each of the two drugs (artesunate or amodiaquine )
- To determine reasons for differential compliance to either of the two drugs (artesunate or amodiaquine).
- To determine patients perception and acceptance of artesunate-amodiaquine therapy for acute uncomplicated malaria.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The main outcome is compliance to artesunate-amodiaquine combination therapy
Time Frame: Within first three days after diagnosis of malaria
Secondary Outcomes
- Reasons for non-compliance(Within 28 days after diagnosis of malaria)
- Participants' perception and acceptance of supervision(Within 28 days after diagnosis of malaria)
- Parasite clearance rates on day 14 and 28(Within 28 days after diagnosis of malaria)
