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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Liverpool School of Tropical Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine
National Malaria Control Programme, Malawi
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
National Malaria Control Programme, Malawi
Research for Equity and Community Health Trust
Investigators
Principal Investigator: David Lalloo, MD Liverpool School of Tropical Medicine
  More Information

Additional Information:
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-lumefantrine combination
Artemisinins
Lumefantrine
Artemether
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on September 29, 2014