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Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial

Author

Listed:
  • Yi Poravuth
  • Duong Socheat
  • Ronnatrai Rueangweerayut
  • Chirapong Uthaisin
  • Aung Pyae Phyo
  • Neena Valecha
  • B H Krishnamoorthy Rao
  • Emiliana Tjitra
  • Asep Purnama
  • Isabelle Borghini-Fuhrer
  • Stephan Duparc
  • Chang-Sik Shin
  • Lawrence Fleckenstein

Abstract

Background: New antimalarials are needed for P. vivax and P. falciparum malaria. This study compared the efficacy and safety of pyronaridine-artesunate with that of chloroquine for the treatment of uncomplicated P. vivax malaria. Methods and Findings: This phase III randomized, double-blind, non-inferiority trial included five centers across Cambodia, Thailand, India, and Indonesia. In a double-dummy design, patients (aged >3–≤60 years) with microscopically confirmed P. vivax mono-infection were randomized (1∶1) to receive pyronaridine-artesunate (target dose 7.2∶2.4 mg/kg to 13.8∶4.6 mg/kg) or chloroquine (standard dose) once daily for three days. Each treatment group included 228 randomized patients. Outcomes for the primary endpoint, Day-14 cure rate in the per-protocol population, were 99.5%, (217/218; 95%CI 97.5, 100) with pyronaridine-artesunate and 100% (209/209; 95%CI 98.3, 100) with chloroquine. Pyronaridine was non-inferior to chloroquine: treatment difference −0.5% (95%CI −2.6, 1.4), i.e., the lower limit of the 2-sided 95%CI for the treatment difference was greater than −10%. Pyronaridine-artesunate cure rates were non-inferior to chloroquine for Days 21, 28, 35 and 42. Parasite clearance time was shorter with pyronaridine-artesunate (median 23.0 h) versus chloroquine (32.0 h; p

Suggested Citation

  • Yi Poravuth & Duong Socheat & Ronnatrai Rueangweerayut & Chirapong Uthaisin & Aung Pyae Phyo & Neena Valecha & B H Krishnamoorthy Rao & Emiliana Tjitra & Asep Purnama & Isabelle Borghini-Fuhrer & Step, 2011. "Pyronaridine-Artesunate versus Chloroquine in Patients with Acute Plasmodium vivax Malaria: A Randomized, Double-Blind, Non-Inferiority Trial," PLOS ONE, Public Library of Science, vol. 6(1), pages 1-12, January.
    • Handle: RePEc:plo:pone00:0014501
    DOI: 10.1371/journal.pone.0014501
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