Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
NCT01038063 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2010-12-09
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).
Conditions
Interventions
- DRUG
-
Artemether-lumefantrine combination
Sponsors & Collaborators
-
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
collaborator OTHER -
National Malaria Control Programme, Malawi
collaborator OTHER_GOV -
Research for Equity and Community Health Trust
collaborator UNKNOWN -
Liverpool School of Tropical Medicine
lead OTHER
Principal Investigators
-
David Lalloo, MD · Liverpool School of Tropical Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 4 Months
- Max Age
- 48 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-10-31
- Primary Completion
- 2013-09-30
- Completion
- 2013-09-30
Countries
- Malawi
Study Locations
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