Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period
1 other identifier
interventional
1,200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2010
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 9, 2010
December 1, 2010
2.9 years
December 21, 2009
December 8, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Prevalence of ototoxicity at 18 months and 36 months of enrolment.
At 18 mo and 36 month of follow up
Secondary Outcomes (1)
Incidence of clinical malaria during 18 months and 36 months of follow-up
18 and 36 months of follow up
Study Arms (2)
Artemether-lumefantrine
EXPERIMENTALChildren 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
ACTIVE COMPARATORChildren in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria.
Interventions
Eligibility Criteria
You may qualify if:
- Aged between 4 months and 11 months at the time of randomization
- Bodyweight ≥ 5 kg at the time of randomization
- Provision of informed consent by parent or guardian
- Intention to stay in the study area for the time of the study
You may not qualify if:
- Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
- Intent to reside outside of catchment area during the course of the study
- Known hypersensitivity to the study drug randomized to
- Known pre-existing hearing problem or neurological impairment
- Known need at the time of randomization for concomitant prohibited medication
- Suspected non-compliance with the follow-up schedule
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
Blantyre, 30096, Malawi
Related Publications (1)
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.
PMID: 22232457DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Lalloo, MD
Liverpool School of Tropical Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2009
First Posted
December 23, 2009
Study Start
October 1, 2010
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
December 9, 2010
Record last verified: 2010-12