Journal Article

Treatment of American Cutaneous Leishmaniasis with Miltefosine, an Oral Agent

J. Soto, J. Toledo, P. Gutierrez, R. S. Nicholls, J. Padilla, J. Engel, C. Fischer, A. Voss and J. Berman

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 33, issue 7, pages e57-e61
Published in print October 2001 | ISSN: 1058-4838
Published online October 2001 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/322689
Treatment of American Cutaneous Leishmaniasis with Miltefosine, an Oral Agent

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There is no recognized oral treatment for American cutaneous leishmaniasis. A rising-dose, open-label phase I/II trial of the oral agent miltefosine against Colombian cutaneous leishmaniasis was conducted. Seventy-two male Colombian soldiers (mean weight, 67 kg) received miltefosine at 50–100 mg/day for 3 weeks (for 32 evaluable patients) or at 133–150 mg/day for 3–4 weeks (for 32 evaluable patients). The per-protocol cure rate for 50–100 mg/day was 21 (66%) of 32 patients. The per-protocol cure rate for 133–150 mg/day was 30 (94%) of 32 patients (P = .01, by use of Fisher's exact test). The historic per-protocol cure rate for standard injections of antimony is 93%. “Motion sickness” that did not interfere with normal duties was experienced by 40% of patients and was dose related. Vomiting and diarrhea were reported on ∼2% of treatment days. In this uncontrolled study of oral miltefosine for treatment of patients with American cutaneous leishmaniasis, a dosage of ∼2.25 mg/kg/day for 3–4 weeks was effective and tolerated.

Journal Article.  2720 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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