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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of pyronaridine-artesunate for treatment of uncomplicated Plasmodium falciparum malaria in western Cambodia
Antimicrobial Agents and Chemotherapy, Volume 60, No. 7, Year 2016
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Description
Pyronaridine-artesunate efficacy for the treatment of uncomplicated Plasmodium falciparum malaria was assessed in an area of artemisinin resistance in western Cambodia. This nonrandomized, single-arm, observational study was conducted between 2014 and 2015. Eligible patients were adults or children with microscopically confirmed P. falciparum infection and fever. Patients received pyronaridine-artesunate once daily for 3 days, dosed according to body weight. The primary outcome was an adequate clinical and parasitological response (ACPR) on day 42, estimated by using Kaplan-Meier analysis, PCR adjusted to exclude reinfection. One hundred twenty-three patients were enrolled. Day 42 PCR-crude ACPRs were 87.2% (95% confidence interval [CI], 79.7 to 92.6%) for the overall study, 89.8% (95% CI, 78.8 to 95.3%) for Pursat, and 82.1% (95% CI, 68.4 to 90.2%) for Pailin. Day 42 PCR-adjusted ACPRs were 87.9% (95% CI, 80.6 to 93.2%) for the overall study, 89.8% (95% CI, 78.8 to 95.3%) for Pursat, and 84.0% (95% CI, 70.6 to 91.7%) for Pailin (P = 0.353 by a log rank test). Day 28 PCR-crude and -adjusted ACPRs were 93.2% (95% CI, 82.9 to 97.4%) and 88.1% (95% CI, 75.3 to 94.5%) for Pursat and Pailin, respectively. A significantly lower proportion of patients achieved day 3 parasite clearance in Pailin (56.4% [95% CI, 43.9 to 69.6%]) than in Pursat (86.7% [95% CI, 76.8 to 93.8%]; P = 0.0019). Fever clearance was also extended at Pailin versus Pursat (P < 0.0001). Most patients (95.9% [116/121]) harbored P. falciparum kelch13 C580Y mutant parasites. Pyronaridine-artesunate was well tolerated; mild increases in hepatic transaminase levels were consistent with data from previous reports. Pyronaridine-artesunate efficacy was below the World Health Organization-recommended threshold at day 42 for medicines with a long half-life (90%) for first-line treatment of P. falciparum malaria in western Cambodia despite high efficacy elsewhere in Asia and Africa. (This study has been registered at ClinicalTrials.gov under registration number NCT02389439.). Copyright © 2016, American Society for Microbiology. All Rights Reserved.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC4914696/bin/supp_60_7_3884__index.html
https://efashare.b-cdn.net/share/pmc/articles/PMC4914696/bin/AAC.00039-16_zac005165142so1.pdf
Authors & Co-Authors
Leang, Rithea
Cambodia, Phnom Penh
National Center for Parasitology, Entomology and Malaria Control
Canavati, Sara E.
Thailand, Bangkok
Mahidol Oxford Tropical Medicine Research Unit
Khim, Nimol
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Vestergaard, Lasse Skafte
Switzerland, Geneva
Organisation Mondiale de la Santé
Borghini-Fuhrer, Isabelle
Switzerland, Geneve
Medicines for Malaria Venture
Kim, Saorin
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Denis, Mey Bouth
Switzerland, Geneva
Organisation Mondiale de la Santé
Huy, Rekol
Cambodia, Phnom Penh
National Center for Parasitology, Entomology and Malaria Control
Duparc, Stephan
Switzerland, Geneve
Medicines for Malaria Venture
Dondorp, A. M.
Thailand, Bangkok
Mahidol Oxford Tropical Medicine Research Unit
Menard, Didier
Cambodia, Phnom Penh
Institut Pasteur du Cambodge
Ringwald, Pascal
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 36
Authors: 12
Affiliations: 5
Identifiers
Doi:
10.1128/AAC.00039-16
ISSN:
00664804
Research Areas
Infectious Diseases
Maternal And Child Health