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Title: Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: A phase II, multicenter, randomized, dose-finding clinical trial
Authors: Neena Valecha
Sornchai Looareesuwan
Andreas Martensson
Salim Mohammed Abdulla
Srivicha Krudsood
Noppadon Tangpukdee
Sanjib Mohanty
Saroj K. Mishra
P. K. Tyagi
S. K. Sharma
Joerg Moehrle
Anirudh Gautam
Arjun Roy
Jyoti K. Paliwal
Monica Kothari
Nilanjan Saha
Aditya P. Dash
Anders Björkman
National Institute of Malaria Research India
Ispat General Hospital
Ranbaxy Research Laboratory
Mahidol University
Karolinska University Hospital
Zanzibar Malaria Research Unit of Karolinska Institute
Ifakara Health Institute
Medicines for Malaria Venture
Keywords: Medicine
Issue Date: 15-Sep-2010
Citation: Clinical Infectious Diseases. Vol.51, No.6 (2010), 684-691
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), 100 mg (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/μL were included and were followed up for 28 days. The median time to 90% parasite clearance (PC90) was evaluated. Results: The median PC90was 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 <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. © 2010 by the Infectious Diseases Society of America. All rights reserved.
ISSN: 10584838
Appears in Collections:Scopus 2006-2010

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