Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period
December 8, 2010 updated by: Liverpool School of Tropical Medicine
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
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1200
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Blantyre, Malawi, 30096
- Recruiting
- Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
-
Contact:
- Kamija Phiri, MD PhD
- Phone Number: +265 999 957 048
- Email: kamijaphiri@gmail.com
-
Principal Investigator:
- Kamija Phiri, MD PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- 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
Exclusion criteria
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of ototoxicity at 18 months and 36 months of enrolment.
Time Frame: At 18 mo and 36 month of follow up
|
At 18 mo and 36 month of follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of clinical malaria during 18 months and 36 months of follow-up
Time Frame: 18 and 36 months of follow up
|
18 and 36 months of follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David Lalloo, MD, Liverpool School of Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Anticipated)
September 1, 2013
Study Completion (Anticipated)
September 1, 2013
Study Registration Dates
First Submitted
December 21, 2009
First Submitted That Met QC Criteria
December 22, 2009
First Posted (Estimate)
December 23, 2009
Study Record Updates
Last Update Posted (Estimate)
December 9, 2010
Last Update Submitted That Met QC Criteria
December 8, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.