Miltefosine Plus IL Pentamidine for Bolivian CL

NCT ID: NCT03445897

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-02-21

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Leishmaniasis, Cutaneous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

miltefosine plus intralesional pentamidine

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonathan Berman

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Berman

President

Responsibility Role SPONSOR_INVESTIGATOR

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ABF MP

Identifier Type: -

Identifier Source: org_study_id

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