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

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	University of Ghana Medical School University of Copenhagen
Information provided by:	University of Ghana Medical School
ClinicalTrials.gov Identifier:	NCT00406146

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 III

MedlinePlus related topics:

Malaria

ChemIDplus related topics:

Artesunate Artemether Benflumetol Amodiaquine Amodiaquine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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

Publications indexed to this study:

Adjei GO, Kurtzhals JA, Rodrigues OP, Alifrangis M, Hoegberg LC, Kitcher ED, Badoe EV, Lamptey R, Goka BQ. Amodiaquine-artesunate vs artemether-lumefantrine for uncomplicated malaria in Ghanaian children: a randomized efficacy and safety trial with one year follow-up. Malar J. 2008 Jul 11;7:127.

Study ID Numbers:	91199 / 104. DAN.8-864, GHN-202-M03-M-00
First Received:	November 13, 2006
Last Updated:	November 30, 2006
ClinicalTrials.gov Identifier:	NCT00406146
Health Authority:	Ghana: Ministry of Health

Study placed in the following topic categories:

Benflumetol

Artesunate

Protozoan Infections

Amodiaquine

Clotrimazole

Miconazole

Tioconazole

Parasitic Diseases

Malaria

Artemether

Additional relevant MeSH terms:

Anti-Infective Agents

Antiprotozoal Agents

Coccidiosis

Antiplatyhelmintic Agents

Anthelmintics

Schistosomicides

Pharmacologic Actions

Antimalarials

Antiparasitic Agents

Therapeutic Uses

Antifungal Agents

Amebicides

Coccidiostats

ClinicalTrials.gov processed this record on October 17, 2008