Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: a phase II, multicenter, randomized, dose-finding clinical trial
Language: 
English
Short Title: 
Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria
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 <10%of the patients and were similar in the 3 groups. Biochemistry and hematological analyses did not show any signof 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.

Author(s): 
Valecha, Neena
Looareesuwan, Sornchai
Mårtensson, Andreas
Abdulla, Salim Mohammed
Krudsood, Srivicha
Tangpukdee, Noppadon
Mohanty, Sanjib
Mishra, Saroj K.
Tyagi, P. K.
Sharma, S. K.
Moehrle, Joerg
Gautam, Anirudh
Roy, Arjun
Paliwal, Jyoti K.
Kothari, Monica
Saha, Nilanjan
Dash, Aditya P.
Björkman, Anders
Item Type: 
Journal Article
Publication Title: 
Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Journal Abbreviation: 
Clin. Infect. Dis.
Publication Date: 
9/15/2010
Publication Year: 
2010
Pages: 
684-691
Volume: 
51
Issue: 
6
ISSN: 
1537-6591
DOI: 
10.1086/655831
Library Catalog: 
PubMed
Extra: 
PMID: 20687837

Turabian/Chicago Citation

Neena Valecha, Sornchai Looareesuwan, Andreas Mårtensson, 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 and Anders Björkman. 9/15/2010. "Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: a phase II, multicenter, randomized, dose-finding clinical trial." Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America 51: 6: 684-691. 10.1086/655831.

Wikipedia Citation

<ref> {{Cite journal | doi = 10.1086/655831 | issn = 1537-6591 | volume = 51 | pages = 684-691 | last = Valecha | first = Neena | coauthors = Looareesuwan, Sornchai, Mårtensson, Andreas, Abdulla, Salim Mohammed, Krudsood, Srivicha, Tangpukdee, Noppadon, Mohanty, Sanjib, Mishra, Saroj K., Tyagi, P. K., Sharma, S. K., Moehrle, Joerg, Gautam, Anirudh, Roy, Arjun, Paliwal, Jyoti K., Kothari, Monica, Saha, Nilanjan, Dash, Aditya P., Björkman, Anders | title = Arterolane, a new synthetic trioxolane for treatment of uncomplicated Plasmodium falciparum malaria: a phase II, multicenter, randomized, dose-finding clinical trial | journal = Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America | date = 9/15/2010 | pmid = | pmc = }} </ref>