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Ramharter, Michael; Kurth, Florian; Schreier, Annette C.; Nemeth, Johannes; von Glasenapp, Isabelle; Bélard, Sabine; Schlie, Meike; Kammer, Judith; Koumba, Philemon Koumba; Cisse, Badara; Mordmüller, Benjamin; Lell, Bertrand; Issifou, Saadou; Oeuvray, Claude; Fleckenstein, Lawrence; Kremsner, Peter G.

Fixed-Dose Pyronaridine-Artesunate Combination for Treatment of Uncomplicated Falciparum Malaria in Pediatric Patients in Gabon

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  • Media type: E-Article
  • Title: Fixed-Dose Pyronaridine-Artesunate Combination for Treatment of Uncomplicated Falciparum Malaria in Pediatric Patients in Gabon
  • Contributor: Ramharter, Michael; Kurth, Florian; Schreier, Annette C.; Nemeth, Johannes; von Glasenapp, Isabelle; Bélard, Sabine; Schlie, Meike; Kammer, Judith; Koumba, Philemon Koumba; Cisse, Badara; Mordmüller, Benjamin; Lell, Bertrand; Issifou, Saadou; Oeuvray, Claude; Fleckenstein, Lawrence; Kremsner, Peter G.
  • imprint: University of Chicago Press, 2008
  • Published in: The Journal of Infectious Diseases
  • Language: English
  • ISSN: 0022-1899
  • Keywords: Major Articles and Brief Reports
  • Origination:
  • Footnote:
  • Description: <p>Background. The development of novel artemisinin-combination therapies suitable for the treatment of pediatric patients suffering from malaria is a research priority. The aim of this study was to investigate a novel fixed-dose pyronaridine-artesunate combination for the treatment of uncomplicated falciparum malaria in Gabonese patients 2-14 years old. Methods. The study was designed as an open-label dose-escalation study recruiting 60 pediatric patients sequentially in 4 treatment cohorts: study drugs were administered once daily for 3 days, as tablet coformulations (pyronaridine:artesunate ratios of 6:2, 9:3, and 12:4 mg/kg) and as a granule coformulation (pyronaridine:artesunate ratio of 9:3 mg/kg). The primary end points were tolerability, safety, and pharmacokinetics of pyronaridine-artesunate treatment. Efficacy was treated as a secondary outcome measure. Results. The drugs had a good tolerability and safety profile, at all dose levels. Pharmacokinetic analysis revealed a dose-dependent increase in the maximum plasma/blood concentration and the area under the curve, as well as comparable relative bioavailability for the granule coformulation. Polymerase chain reaction-corrected cure rates at day 28 were 100% in per-protocol analysis, at all dose levels. Conclusions. Pyronaridine-artesunate is a promising novel artemisinin-combination therapy for pediatric patients with uncomplicated Plasmodium falciparum malaria, and the development of both the tablet and the granule coformulations is warranted. Trial Registration. Clinical Trials.gov identifier NCT00331136.</p>
  • Access State: Open Access