Open-label, randomized, non-inferiority clinical trial of artesunate-amodiaquine versus artemether-lumefantrine fixed-dose combinations in children and adults with uncomplicated falciparum malaria in Côte d'Ivoire

Emergence of artemisinin resistance has raised concerns that the most potent anti-malarial drug may be under threat. Artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) are, respectively, the first- and second-line treatments for uncomplicated falciparum malaria in Côte d'Ivoire. Co...

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Bibliographic Details
Published in:Malaria journal 2014-11, Vol.13 (1), p.439-439, Article 439
Main Authors: Toure, Offianan A, Assi, Serge B, N'Guessan, Tiacoh L, Adji, Gbessi E, Ako, Aristide B, Brou, Marie J, Ehouman, Marie F, Gnamien, Laeticia A, Coulibaly, M'Lanhoro A A, Coulibaly, Baba, Beourou, Sylvain, Bassinka, Issiaka, Soumahoro, Adama, Kadjo, Florence, Tano, Mea A
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Amodiaquine - administration & dosage
Antimalarials - administration & dosage
Artemether, Lumefantrine Drug Combination
Artemisinins - administration & dosage
Child
Child, Preschool
Clinical trials
Confidence intervals
Cote d'Ivoire
Derivatives
Drug Combinations
Drug dosages
Ethanolamines - administration & dosage
Failure
Female
Fluorenes - administration & dosage
Humans
Infant
Malaria
Malaria, Falciparum - drug therapy
Male
Middle Aged
Parasites
Reading
Studies
Surveillance
Treatment Outcome
Young Adult
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Summary:Emergence of artemisinin resistance has raised concerns that the most potent anti-malarial drug may be under threat. Artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) are, respectively, the first- and second-line treatments for uncomplicated falciparum malaria in Côte d'Ivoire. Constant monitoring by National Malaria Control Programme (NMCP) of drug efficacy is an important tool in establishing rational anti-malarial drug policies in Côte d'Ivoire. In an open label, randomized controlled clinical trial, children and adults were randomized to receive AS-AQ or AL. Both drug regimens were given for three days, and follow-up was for 42 days. The primary endpoint was the 42-day cure rate and was defined as proportion of patients with PCR-corrected cure rate after 42 days of follow-up. A total of 383 patients who were attending the Anonkoua-koute (Abidjan), Petit Paris (Korhogo) and Libreville (Man) hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive AS-AQ (188) and AL (195). The intention-to-treat analysis showed effectiveness rates of 94.7% and 96.4% for AS-AQ and AL, respectively on day 42. After adjustment for PCR, these rates were 96.8% and 99%, respectively. At day 42, in per-protocol analysis, Adequate clinical and parasitological response (ACPR) PCR uncorrected was 97.8% and 97.4% for AS-AQ and AL, respectively. The PCR adjusted ACPR was 100% for each combination and both regimens were well tolerated. This study has shown the high efficacy of AS-AQ in patients of all ages with acute uncomplicated falciparum malaria and AS-AQ was non-inferior to AL. Continuous efficacy monitoring is recommended.
ISSN:1475-2875
1475-2875
DOI:10.1186/1475-2875-13-439