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Fixed-dose artesunate-amodiaquine combination vs chloroquine for treatment of uncomplicated blood stage P. vivax infection in the Brazilian amazon : an open-label randomized, controlled trial

Siqueira, Andre M. and Alencar, Aline C. and Melo, Gisely C. and Magalhaes, Belisa L. and Machado, Kim and Alencar Filho, Aristóteles C. and Kuehn, Andrea and Marques, Marly M. and Manso, Monica Costa and Felger, Ingrid and Vieira, José L. F. and Lameyre, Valerie and Daniel-Ribeiro, Claudio T. and Lacerda, Marcus V. G.. (2017) Fixed-dose artesunate-amodiaquine combination vs chloroquine for treatment of uncomplicated blood stage P. vivax infection in the Brazilian amazon : an open-label randomized, controlled trial. Clinical infectious diseases, 64 (2). pp. 166-174.

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Abstract

Despite increasing evidence of the development of Plasmodium vivax chloroquine (CQ) resistance, there have been no trials comparing its efficacy with that of artemisinin-based combination therapies (ACTs) in Latin America.; This randomized controlled trial compared the antischizontocidal efficacy and safety of a 3-day supervised treatment of the fixed-dose combination artesunate-amodiaquine Winthrop(®) (ASAQ) versus CQ for treatment of uncomplicated P. vivax infection in Manaus, Brazil. Patients were followed for 42 days. Primary endpoints were adequate clinical and parasitological responses (ACPR) rates at day 28. Genotype-adjustment was performed.; From 2012 to 2013, 380 patients were enrolled. In the per-protocol (PP) analysis, adjusted-ACPR was achieved in 100% (165/165) and 93.6% (161/172) of patients in the ASAQ and CQ arm (difference 6.4%, 95% CI 2.7%; 10.1%) at day 28 and in 97.4% (151/155) and 77.7% (129/166), respectively (difference 19.7%, 95% CI 12.9%; 26.5%), at day 42. Apart from ITT D28 assessment, superiority of ASAQ on ACPR was demonstrated. ASAQ presented faster clearance of parasitaemia and fever. Based on CQ blood level measurements, CQ resistance prevalence was estimated at 11.5% (95% CI: 7.5-17.3) up to day 42. At least one emergent adverse event (AE) was recorded for 79/190 (41x6%) in the ASAQ group and for 85/190 (44x7%) in the CQ group. Both treatments had similar safety profiles.; ASAQ exhibited high efficacy against CQ resistant P. vivax and is an adequate alternative in the study area. Studies with an efficacious comparator, longer follow-up and genotype-adjustment can improve CQR characterization.; NCT01378286.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Molecular Diagnostics (Felger)
UniBasel Contributors:Felger, Ingrid
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Oxford University Press
ISSN:1058-4838
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:25 Oct 2017 10:38
Deposited On:24 Apr 2017 13:39

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