Miltefosine Plus IL Pentamidine for Bolivian CL

Jonathan Berman

Status and phase: Completed; Phase 2

Conditions: Leishmaniasis, Cutaneous

Treatments: Drug: miltefosine plus intralesional pentamidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03445897

ABF MP

Details and patient eligibility

About

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Full description

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

Enrollment: 50 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• one ulcerative lesion ≤ 900 mm2 in total area,
• ≥ 12 years,
• parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
• no antileishmanial therapy in the last 3 months,
• no mucosal lesions,
• no history of significant concomitant diseases including immunosuppression.

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Intervention

Experimental group

Description:

miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Treatment:

Drug: miltefosine plus intralesional pentamidine