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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.
Received December 4, 2006. Accepted for publication July 2, 2007.
Acknowledgments: We thank Pedro Rueda, Diego Marco, Sergio Sosa-Estani, Silvia Gallerano, and Julio Cortes for collaborating on this project, Pedro Cahn for support and guidance, and Marina Travacio for careful review of the manuscript.
Financial support: This study was supported by an educational grant from Pfizer and by research grant Ramón Carrillo-Arturo Oñativia 2002. CONAPRIS Res. 170/02 from the Ministerio de Salud-Presidencia de la Nación Argentina.
* Address correspondence to Alejandro J. Krolewiecki, Area de Investigaciones Clinicas, Fundacion Huesped, Pje Angel Peluffo 3932, Buenos Aires (C1202ABB) Argentina. E-mail: alekrol{at}huesped.org.ar
Authors’ addresses: Alejandro J Krolewiecki, Area de Investigaciones Clinicas, Fundacion Huesped, Pje Angel Peluffo 3932, Buenos Aires (C1202ABB) Argentina, Telephone: 54-11-4981-1855, Fax: 54-11-4982-4024, E-mail: alekrol{at}huesped.org.ar. Hector D. Romero, Silvana P. Cajal, Marisa Juarez, and Nestor J. Taranto, Instituto de Investigaciones en Enfermedades Tropicales, UNSa Sede Regional Oran, Alvarado 751, San Ramon de la Nueva Oran, Salta (4530) Argentina, Telephone and Fax: 54-38-78-421924, E-mails: hdardo_r_f{at}hotmail.com, spcajal{at}yahoo.com, marjualu{at}yahoo.com.ar, and ntaranto{at}arnet.com.ar. David Abraham, Department of Microbiology and Immunology, Kimmel Cancer Center, Thomas Jefferson University, 233 South 10th Street, Suite 503, Philadelphia, PA 19107, Telephone: 215-503-8917, Fax: 215-503-0622, E-mail: david.abraham{at}jefferson.edu; Tatsuyuki Mimori Department of Microbiology, School of Health Sciences, Kumamoto University, Kuhonji 4-24-1, Kumamoto 862-0976, Japan, Telephone and Fax: 81-96-373-5493, E-mail: mimori{at}hs.kumamoto-u.ac.jp. Tamami Matsumoto, Department of Medical Technology Kumamoto Health Science University, Izumimachi 325, Kumamoto 861-5598, Japan, Telephone and Fax: 81-96-275-2169, E-mail: matumoto{at}kumamoto-hsu.ac.jp.
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