title: Randomized single-blinded non-inferiority trial of 7 mg/kg pentamidine isethionate versus 4 mg/kg pentamidine isethionate for cutaneous leishmaniaisis in Suriname.
abstract: BACKGROUND
  Standard treatment of cutaneous leishmaniasis (CL) in Suriname entails three injections of pentamidine isethionate (PI) 4 mg/kg per injection in 7 days (7 day regimen). Compliance to treatment is low and may contribute to increasing therapy failure. A 3 day regimen, including 2 injections of 7 mg/kg in 3 days may increase compliance.
  
  
  METHODS
  In a randomized, single-blinded non-inferiority trial conducted in Suriname, 84 CL patients received the 7 day regimen and 79 CL patients received the 3 day regimen. Primary objective was the proportion of patients clinically cured at 6 weeks follow-up. Secondary objectives were clinical cure at 12 weeks follow-up; parasitological cure at 6 and 12 weeks; adverse and drug related toxicity events recorded one week after the end of treatment and health related quality of life. The non-inferiority margin was set at 15%, 1 sided test, α = 0.1.
  
  
  RESULTS
  At 6 weeks follow-up 31 (39%) patients in the 3 day regimen and 41 (49%) patients in the 7 day regimen were clinically cured. Intention to treat (ITT) analyses showed that the difference in proportion clinically cured was -9.6% (90% Confidence Interval (CI): -22.3% to 3.2%). Per protocol (PP) analysis showed that the difference in proportion clinically cured was 0.2% (90% CI: -14.6% to 15.2%). ITT analysis showed that the difference in proportion parasitological cured at 6 weeks was -15.2% (90% CI:-28.0% to -2.5%). PP analyses showed similar results. Non-inferiority could not be concluded for all adverse and toxicological events.
  
  
  CONCLUSIONS
  We cannot conclude that the 3 day regimen is non-inferior to the 7 day regimen regarding proportion clinically and parasitological cured. Therefore there is no evidence to change the current standard practice of the 7 day regimen for the treatment of CL in Suriname.
authors: Dermatology Service, Ministry of Health, Paramaribo, Suriname.
authors: Ricardo V P F
authors: RV
authors: Hu
authors: Department of Biomedical Research, Royal Tropical Institute, KIT, Amsterdam, The Netherlands.
authors: Masja
authors: M
authors: Straetemans
authors: Department of Parasitology, Anton de Kom University of Suriname, Paramaribo, Suriname.
authors: Alida D
authors: AD
authors: Kent
authors: Dermatology Service, Ministry of Health, Paramaribo, Suriname.
authors: Leslie O A
authors: LO
authors: Sabajo
authors: Centre for Infections and Immunity Amsterdam (CINIMA), Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; Department of Dermatology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands; STI Outpatient Clinic, Cluster Infectious Diseases, Public Health Service Amsterdam, Amsterdam, The Netherlands.
authors: Henry J C
authors: HJ
authors: de Vries
authors: Department of Dermatology, Academic Hospital, Paramaribo, Suriname.
authors: Rudy F M Lai A
authors: RF
authors: Fat
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D016773:Leishmaniasis, Cutaneous / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010419:Pentamidine / Q000008:administration & dosage* / Q000494:pharmacology*; D011788:Quality of Life; D013532:Suriname; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010419:Pentamidine