Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University of Ghana Medical School.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University of Ghana Medical School
ClinicalTrials.gov Identifier:
NCT00406146
First received: November 13, 2006
Last updated: November 30, 2006
Last verified: November 2006
  Purpose

Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.


Condition Intervention Phase
Uncomplicated Malaria
Drug: amodiaquine+artesunate/artemether-lumefantrine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Ghana Medical School:

Study Start Date: October 2004
Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   6 Months to 14 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • microscopically confirmed acute uncomplicated falciparum malaria;
  • temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
  • willingness to comply with follow up schedule;
  • written informed consent by accompanying parent or guardian

Exclusion Criteria:

  • features of severe malaria or danger signs of malaria
  • known intolerance or allergy to any of the study medications
  • known treatment with any of the study medications in the month preceding enrollment
  • serious underlying disease that may mask outcome assessment
  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: NCT00406146

Locations
Ghana
Korle Bu Teaching Hospital
Accra, Ghana
Sponsors and Collaborators
University of Ghana Medical School
University of Copenhagen
Investigators
Principal Investigator: George O. Adjei, MD Dept. of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Principal Investigator: Bamenla Q. Goka, MBchB Dept of Child Health, Korle Bu Teaching Hospital, Accra, Ghana
Principal Investigator: Jorgen A.L. Kurtzhals, MD, Ph.D Dept. of Clinical Microbiology, Copenhagen University Hospital (Rigshospitalet), Copenhagen, Denmark
  More Information

No publications provided by University of Ghana Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00406146     History of Changes
Other Study ID Numbers: 91199 / 104. DAN.8-864, GHN-202-M03-M-00
Study First Received: November 13, 2006
Last Updated: November 30, 2006
Health Authority: Ghana: Ministry of Health

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

ClinicalTrials.gov processed this record on October 22, 2014