Document Detail


Arterolane maleate and Piperaquine phosphate combination for the treatment of uncomplicated Plasmodium falciparum malaria: a comparative, multicentre randomized clinical trial.
MedLine Citation:
PMID:  22586253     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BackgroundArtemisinin based combination therapy (ACT) is the first-line treatment for uncomplicated falciparum malaria. The current study assessed the antimalarial efficacy and safety of a combination of 150 mg of arterolane maleate and 750 mg of piperaquine phosphate in comparison to Coartem(®) (artemether and lumefantrine) in patients with acute uncomplicated P. falciparum malaria.MethodsIn this open label, randomized, multicentric, parallel group clinical trial, 240 patients were randomized to receive arterolane maleate + piperaquine phosphate (160 patients) or Coartem(®) (80 patients). Patients with P. falciparum monoinfection and initial parasite densities ranging from 1000 to 100,000 asexual parasites/µL of blood were followed-up for 28 days. PCR-corrected ACPR (Adequate Clinical and Parasitologic Response) on day 28, parasite clearance time (PCT) and fever clearance time (FCT) were evaluated.ResultsA total of 151 (94.4%) out of 160 patients completed the trial in arterolane maleate + piperaquine phosphate group while 77 (96.3%) out of 80 patients in Coartem(®) group completed the trial. No treatment failure was noted in arterolane maleate + piperaquine phosphate group while one patient receiving Coartem was identified as treatment failure on Day 28. There was no difference in the median PCT (30 hours in both groups) and median FCT (24 hours in both groups) after administration of the two study treatments.ConclusionThe available data support the evaluation of drug combination in a larger population as fixed dose combination.
Authors:
Neena Valecha; Srivicha Krudsood; Noppadon Tangpukdee; Sanjib Mohanty; S K Sharma; P K Tyagi; Anupkumar Anvikar; Rajesh Mohanty; Bs Rao; Ac Jha; B Shahi; Jai Prakash Narayan Singh; Arjun Roy; Pawandeep Kaur; Monica Kothari; Shantanu Mehta; Anirudh Gautam; Jyoti K Paliwal; Sudershan Arora; Nilanjan Saha
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-5-14
Journal Detail:
Title:  Clinical infectious diseases : an official publication of the Infectious Diseases Society of America     Volume:  -     ISSN:  1537-6591     ISO Abbreviation:  -     Publication Date:  2012 May 
Date Detail:
Created Date:  2012-5-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9203213     Medline TA:  Clin Infect Dis     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
National Institute of Malaria Research, New Delhi, India.
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