A Randomized Clinical Trial Comparing Oral Azithromycin and Meglumine Antimoniate for the Treatment of American Cutaneous Leishmaniasis Caused by Leishmania (Viannia) braziliensis

Alejandro J. Krolewiecki Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Héctor D. Romero Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Silvana P. Cajal Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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David Abraham Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Tatsuyuki Mimori Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Tamami Matsumoto Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Marisa Juarez Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Nestor J. Taranto Instituto de Investigaciones en Enfermedades Tropicales, Universidad Nacional de Salta, Sede Regional Orán, San Ramón de la Nueva Orán, Salta, Argentina; Área de Investigaciones Clínicas, Fundación Huésped, Buenos Aires, Argentina; Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania; Departments of Microbiology and Medical Technology, School of Health Sciences, Kumamoto University, Kumamoto, Japan

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Azithromycin was compared with meglumine antimoniate for treatment of patients with cutaneous leishmaniasis. Patients were randomized to receive oral azithromycin, 500 mg/day (22 patients) or intramuscular meglumine antimoniate, 10 mg Sb/kg/day (23 patients), both for 28 days, with a second cycle of 15 days if necessary, and followed-up for one year after completion of treatment. Efficacy, defined as complete re-epithelization without relapse for 12 months after completing therapy, was 82.6% (95% confidence interval [CI] = 67–98%) for meglumine antimoniate and 45.5% (95% CI = 25–66%) for azithromycin. All patients who failed treatment with azithromycin were treated with meglumine antimoniate and clinically cured. Azithromycin was well tolerated; meglumine antimoniate caused arthralgias and local symptoms in 78% of the patients. In 17 cases, species identification was obtained; Leishmania (Viannia) braziliensis was identified in all of them. For the treatment of American cutaneous leishmaniasis caused by L. (V.) braziliensis, meglumine antimoniate is significatively more efficacious than azithromycin, which was clinically curative in almost half of the patients and well-tolerated.

Author Notes

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