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

Abstract

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.

Leishmaniasis in travelers: A literature review

“…The drug is less efficient against L. [L.] braziliensis infections [147,148]. The drug is administered at a dose of 300 mg once weekly for 3e5 weeks [132].…”

Urban Transmission of American Cutaneous Leishmaniasis in Argentina: Spatial Analysis Study

“…2 The etiologic agents are protozoan parasites of the genus Leishmania , and the predominant species in this area has been identified as Leishmania ( Viannia ) braziliensis , although Leishmania ( Leishmania ) amazonensis and Leishmania ( V. ) guyanensis have also been identified in a few cases. 3,4 The sand fly vectors of this disease belong to the family Psychodidae and the subfamily Phlebotominae. In this region, the species that have been previously described are Lutzomyia neivai , Lu.…”

Restricted Outbreak of American Tegumentary Leishmaniasis with High Microfocal Transmission

“…The patient with lesions on his thorax and face (#2 in Tables 1 and 2) required a second cycle of meglumine antimoniate followed by a course of oral azithromycin for 4 weeks to achieve clinical cure. 6 No relapses have been observed a year after clinical cure.…”

“…All were treated with meglumine antimoniate at 10 mg/kg/day for 21 to 28 days, the standard practice in the area, which has demonstrated a short term efficacy 95% in observational and pilot randomized prospective studies. 6,17 The patient presenting with MCL required two cycles of meglumine antimoniate followed by a 28-day cycle of amphotericin-B deoxycolate to achieve full clinical resolution. The patient with lesions on his thorax and face (#2 in Tables 1 and 2) required a second cycle of meglumine antimoniate followed by a course of oral azithromycin for 4 weeks to achieve clinical cure.…”

“…[3][4][5] To date, the clinical forms of leishmaniasis reported in this region are cutaneous (CL) and mucocutaneous leishmaniasis (MCL), and the predominant species isolated from these autochthonous cases has predominantly been Leishmania (Viannia) braziliensis; though few cases caused by Leishmania (Viannia) guyanensis and Leishmania (Leishmania) amazonensis have also been reported. 6,7 Recently, autochthonous transmission of visceral leishmaniasis caused by Leishmania (Leishmania) infantum was also reported in Salta. 8 Lutzomyia neivai has been found to harbor the parasite L. (Viannia) spp., and is the vector most frequently associated with American cutaneous leishmaniasis transmission in both endemic and outbreak events in Argentina.…”