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Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period

This study is currently recruiting participants.
Verified December 2010 by Liverpool School of Tropical Medicine
Sponsor:
Collaborators:
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine
Malawi National Malaria Control Programme
Research for Equity and Community Health Trust
Information provided by:
Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01038063
First received: December 21, 2009
Last updated: December 8, 2010
Last verified: December 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Malaria
 Drug: Artemether-lumefantrine combination
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Liverpool School of Tropical Medicine:

Primary Outcome Measures:
  • Prevalence of ototoxicity at 18 months and 36 months of enrolment. [ Time Frame: At 18 mo and 36 month of follow up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of clinical malaria during 18 months and 36 months of follow-up [ Time Frame: 18 and 36 months of follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: Artemether-lumefantrine combination
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.
 Drug: Artemether-lumefantrine combination

  Eligibility

Ages Eligible for Study:   4 Months to 48 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Aged between 4 months and 11 months at the time of randomization
  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

  1. Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038063

Contacts
Contact: David Lalloo, MD +44 151 705 3179 dlalloo@liverpool.ac.uk
Contact: Kamija Phiri, MD PhD +265 999 957 048 kamijaphiri@gmail.com

Locations
Malawi
Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine Recruiting
Blantyre, Malawi, 30096
Contact: Kamija Phiri, MD PhD     +265 999 957 048     kamijaphiri@gmail.com    
Principal Investigator: Kamija Phiri, MD PhD            
Sponsors and Collaborators
Liverpool School of Tropical Medicine
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine
Malawi National Malaria Control Programme
Research for Equity and Community Health Trust
Investigators
Principal Investigator: David Lalloo, MD Liverpool School of Tropical Medicine
  More Information

Additional Information:
The ACT Consortium is a global research partnership formed in November 2007 to answer key questions on malaria drug delivery in Africa and Asia.  This link exits the ClinicalTrials.gov site

No publications provided by Liverpool School of Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sian Roberts / Head of Research Management, Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT01038063     History of Changes
Other Study ID Numbers: 09.07
Study First Received: December 21, 2009
Last Updated: December 8, 2010
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Dihydroquinghaosu
Lumefantrine
Artemether-lumefantrine combination
Artemisinins
Antifungal Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on June 17, 2013