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Randomized Controlled Trial
. 2015 Mar 20;9(3):e0003592.
doi: 10.1371/journal.pntd.0003592. eCollection 2015 Mar.

Randomized single-blinded non-inferiority trial of 7 mg/kg pentamidine isethionate versus 4 mg/kg pentamidine isethionate for cutaneous leishmaniaisis in Suriname

Ricardo V P F Hu  1 , Masja Straetemans  2 , Alida D Kent  3 , Leslie O A Sabajo  1 , Henry J C de Vries  4 , Rudy F M Lai A Fat  5
Affiliations
Randomized Controlled Trial

Randomized single-blinded non-inferiority trial of 7 mg/kg pentamidine isethionate versus 4 mg/kg pentamidine isethionate for cutaneous leishmaniaisis in Suriname

Ricardo V P F Hu et al. PLoS Negl Trop Dis. .

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.

Conclusion: 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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. PELESU study in patients with cutaneous leishmaniasis in Suriname from 2010–2013: study enrollment, randomization and follow-up.
See this image and copyright information in PMC

References

    1. World Health Organization. (2010) Control of the leishmaniasis. World Health Organ Tech Rep Ser 949: 62–71. - PubMed
    1. Burgos AHJ. (1994) Annotated list of phlebotominae (diptera) in Suriname. Mem Inst Oswaldo Cruz 89: 171–178.
    1. Lai A Fat EJ, Vrede MA, Soetosenojo RM, Lai A Fat RF. (2002) Pentamidine, the drug of choice for the treatment of cutaneous leishmaniasis in Surinam. Int J Dermatol 41: 796–800. - PubMed
    1. van der Meide WF, Sabajo LO, Jensema AJ, et al. (2009) Evaluation of treatment with pentamidine for cutaneous leishmaniasis in Suriname. Int J Dermatol 48: 52–58. 10.1111/j.1365-4632.2009.03883.x - DOI - PubMed
    1. Croft SL, Sundar S, Fairlamb AH. (2006) Drug resistance in leishmaniasis. Clin Microbiol Rev 19: 111–126. - PMC - PubMed

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