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Antihelminthic Therapy and Antimony in Cutaneous Leishmaniasis: A Randomized, Double-Blind, Placebo-Controlled Trial in Patients Co-Infected with Helminths and Leishmania braziliensis

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  • College of Medicine, University of Arizona, Tucson, Arizona; Serviço de Imunologia, Complexo Hospitalar Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil; Division of Infectious Diseases, Department of Medicine, Weill Cornell Medical College, New York; Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil

Helminth infections influence the clinical response to certain diseases and are associated with delayed healing time of patients with cutaneous leishmaniasis (CL) caused by Leishmania braziliensis. We conducted a randomized, double-blind, placebo-controlled clinical trial to examine the role of early versus deferred treatment of intestinal helminth infection on the clinical course of patients with CL treated with pentavalent antimony. (Clinicaltrials.gov number NCT00469495). A total of 90 patients were enrolled, 51.1% (N = 23) of control patients had persistent lesions at Day 90, compared with 62.2% (N = 28) in the treatment group (difference 11.1%, 95% confidence interval = −9.1–30.0%). There was no statistically significant difference in overall time to cure between groups, although there was a tendency for shorter cure times in the control group. This study shows that early introduction of antihelminthic therapy does not improve clinical outcome in patients co-infected with helminths and L. braziliensis.

Author Notes

*Address correspondence to Paulo R. Machado, Serviço de Imunologia, Complexo Hospitalar Universitário Prof. Edgard Santos, UFBA, Rua João das Botas s/n, Canela, 40110-160, BA, Brazil. E-mail: prlmachado@pq.cnpq.br/imuno@ufba.br

Financial support: This study was supported by NIH/FIC grant D43 TW007127 and NIH/NIAID K24AI078884.

Authors' addresses: Tracey Newlove, Department of Dermatology, New York University, New York, NY, E-mail: tracey.newlove@nyumc.org. Luiz H. Guimarães, Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil, E-mail: luizhenriquesg@yahoo.com.br. Daniel J. Morgan, Departments of Epidemiology and Preventive Medicine, University of Maryland, Baltimore, MD, E-mail: dmorgan@epi.umaryland.edu. Leda Alcântara, Faculdade de Farmácia, Universidade Federal da Bahia, Salvador, Bahia, Brazil, E-mail: alcantar@ufba.br. Marshall J. Glesby, Division of International Medicine and Infectious Diseases, Department of Medicine, Weill Medical College of Cornell University, New York, NY, E-mail: mag2005@med.cornell.edu. Edgar M. Carvalho, Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil, E-mail: imuno@ufba.br. Paulo R. Machado, Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil, E-mail: prlmachado@uol.com.br.

Reprint requests: Paulo R. Machado, Serviço de Imunologia, Complexo Hospitalar Universitário Prof. Edgard Santos, UFBA, Rua João das Botas s/n, Canela, 40110-160, BA, Brazil, E-mail: prlmachado@pq.cnpq.br/imuno@ufba.br.

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