# name
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

# metadata.dc.description.abstract[].value
BACKGROUND: 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. METHODS: This
                randomized controlled trial compared the antischizontocidal
                efficacy and safety of a 3-day supervised treatment of the
                fixed-dose combination artesunate-amodiaquine Winthrop(R) (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.
                RESULTS: 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. CONCLUSIONS: 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.

# metadata.dc.relation.isformatof[].value
Reproducció del document publicat a:
                http://dx.doi.org/10.1093/cid/ciw706

# metadata.dc.relation.ispartof[].value
Clinical Infectious Diseases, 2017, vol. 64, num. 2, p. 166-174

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
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