Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
Phase 4
- Conditions
- Malaria
- Interventions
- Drug: Artemether-lumefantrine combination
- Registration Number
- NCT01038063
- Lead Sponsor
- Liverpool School of Tropical Medicine
- Brief Summary
A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Artemether-lumefantrine Artemether-lumefantrine combination Children in this study arm will be treated with artemether-lumefantrine during a three year follow-up period each time a child develops uncomplicated malaria. Dihydroartemisinin-piperaquine Artemether-lumefantrine combination Children in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria.
- Primary Outcome Measures
Name Time Method Prevalence of ototoxicity at 18 months and 36 months of enrolment. At 18 mo and 36 month of follow up
- Secondary Outcome Measures
Name Time Method Incidence of clinical malaria during 18 months and 36 months of follow-up 18 and 36 months of follow up
Trial Locations
- Locations (1)
Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
🇲🇼Blantyre, Malawi