Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: a phase II, multicenter, randomized, dose-finding clinical trial

  • Valecha N
  • Looareesuwan S
  • Martensson A
 et al. 
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Abstract

BACKGROUND: Drug-resistant Plasmodium falciparum malaria necessitates development of novel drugs for treatment.The present study assessed the efficacy and safety of 3 dose levels of arterolane (RBx 11160), a synthetic trioxolane, for treatment of acute uncomplicated falciparum malaria. METHODS: In this randomized, double-blind, multicenter, parallel-group, dose-finding, phase II trial, 230 patients from 4 centers in Thailand, India, and Tanzania (mainland and Zanzibar) received either 50 mg (n=78), 100mg (n=76), or 200 mg (n=76) of arterolane once daily for 7 days. Patients (aged 13-65 years) with asexual parasite density of 1000-100,000 parasites/microL were included and were followed up for 28 days. The median time to 90% parasite clearance (PC90) was evaluated. RESULTS: The median PC90 was longer in the group receiving the 50-mg dose (19.4 h), compared with the groups receiving the 100-mg dose (12.8 h) and 200-mg dose (12.6 h) (P < .01). The polymerase chain reaction-corrected adequate clinical and parasitological responses on day 28 were 63%, 71%, and 72% for the groups receiving the 50-mg, 100-mg, and 200-mg doses, respectively, by intention-to-treat analysis (odds ratio, 1.55; 95%confidence interval, 0.78-3.06, for comparison of the 200-mg and 50-mg dose groups). Treatment was generally well tolerated. No patient died or experienced any serious adverse event. Mild complaints were reported in

Author-supplied keywords

  • Adolescent
  • Adult
  • Aged
  • Antimalarials/*administration & dosage/adverse eff
  • Double-Blind Method
  • Female
  • Heterocyclic Compounds, 1-Ring/*administration & d
  • Humans
  • India
  • Malaria, Falciparum/*drug therapy
  • Male
  • Middle Aged
  • Peroxides/*administration & dosage/adverse effects
  • Plasmodium falciparum/drug effects/*isolation & pu
  • Spiro Compounds/*administration & dosage/adverse e
  • Tanzania
  • Thailand
  • Treatment Outcome
  • Young Adult
  • effects/pharmacology

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Authors

  • N Valecha

  • S Looareesuwan

  • A Martensson

  • S M Abdulla

  • S Krudsood

  • N Tangpukdee

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