Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
NCT ID: NCT01038063
Last Updated: 2010-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1200 participants
INTERVENTIONAL
2010-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Artemether-lumefantrine
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.
Artemether-lumefantrine combination
Dihydroartemisinin-piperaquine
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.
Artemether-lumefantrine combination
Interventions
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Artemether-lumefantrine combination
Eligibility Criteria
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Inclusion Criteria
2. Bodyweight ≥ 5 kg at the time of randomization
3. Provision of informed consent by parent or guardian
4. Intention to stay in the study area for the time of the study
Exclusion Criteria
2. Intent to reside outside of catchment area during the course of the study
3. Known hypersensitivity to the study drug randomized to
4. Known pre-existing hearing problem or neurological impairment
5. Known need at the time of randomization for concomitant prohibited medication
6. Suspected non-compliance with the follow-up schedule
4 Months
48 Months
ALL
No
Sponsors
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Malawi-Liverpool-Wellcome Trust Clinical Research Programme
OTHER
National Malaria Control Programme, Malawi
OTHER_GOV
Research for Equity and Community Health Trust
UNKNOWN
Liverpool School of Tropical Medicine
OTHER
Responsible Party
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Liverpool School of Tropical Medicine
Principal Investigators
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David Lalloo, MD
Role: PRINCIPAL_INVESTIGATOR
Liverpool School of Tropical Medicine
Locations
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Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
Blantyre, , Malawi
Countries
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Central Contacts
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Facility Contacts
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Kamija Phiri, MD PhD
Role: primary
References
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Roca-Feltrer A, Lalloo DG, Phiri K, Terlouw DJ. Rolling Malaria Indicator Surveys (rMIS): a potential district-level malaria monitoring and evaluation (M&E) tool for program managers. Am J Trop Med Hyg. 2012 Jan;86(1):96-8. doi: 10.4269/ajtmh.2012.11-0397.
Other Identifiers
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09.07
Identifier Type: -
Identifier Source: org_study_id