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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 ([Formula: see text]), 100 mg ([Formula: see text]), or 200 mg ([Formula: see text]) of arterolane once daily for 7 days. Patients (aged 13-65 years) with asexual parasite density of 1000-100,000 parasites/muL were included and were followed up for 28 days. The median time to 90% parasite clearance (PC(90)) was evaluated. Results. The median PC(90) 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) ([Formula: see text]). 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 <10% of the patients and were similar in the 3 groups. Biochemistry and hematological analyses did not show any sign of drug toxicity in any patient. Conclusion. Arterolane at daily doses of 100 and 200 mg is a rapidly acting, effective, and safe synthetic antimalarial drug, which may potentially represent an alternative to artemisinin derivatives in antimalarial combination therapy. Trial registration. ClinicalTrials.gov identifier NCT00362050.
National Institute of Malaria Research, Indian Council of Medical Research, Delhi, 2Ispat General Hospital and 3Field Station, Malaria Research Centre, Rourkela, and 4Ranbaxy Laboratories, Gurgaon, India; 5Faculty of Tropical Medicine, Mahidol University,
This article was published in the following journal.
Name: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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A species of protozoa that is the causal agent of falciparum malaria (MALARIA, FALCIPARUM). It is most prevalent in the tropics and subtropics.
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