Miltefosine Plus IL Pentamidine for Bolivian CL

Leishmaniasis, Cutaneous Clinical Trial

Official title:

Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445897
• Other study ID #: ABF MP
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2018
• Last updated: February 23, 2018
• Start date: January 31, 2016
• Est. completion date: February 21, 2018

Study information

• Verified date: February 2018
• Source: AB Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 21, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jonathan Berman

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion size	area of lesion	6 months post therapy
Secondary	adverse effects at site	pain, erythema, edema	days 1, 3, 5 of therapy
Secondary	systemic adverse effects	gastrointestinal side effects	days 1 to 28 of therapy