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Miltefosine Plus IL Pentamidine for Bolivian CL

Primary Purpose

Leishmaniasis, Cutaneous

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
miltefosine plus intralesional pentamidine
Sponsored by
Jonathan Berman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leishmaniasis, Cutaneous

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Lesion size
    area of lesion

    Secondary Outcome Measures

    adverse effects at site
    pain, erythema, edema
    systemic adverse effects
    gastrointestinal side effects

    Full Information

    First Posted
    February 21, 2018
    Last Updated
    February 23, 2018
    Sponsor
    Jonathan Berman
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03445897
    Brief Title
    Miltefosine Plus IL Pentamidine for Bolivian CL
    Official Title
    Miltefosine Combined With Intralesional Pentamidine for Leishmania Braziliensis Cutaneous Leishmaniasis in Bolivia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 31, 2016 (Actual)
    Primary Completion Date
    January 31, 2018 (Actual)
    Study Completion Date
    February 21, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jonathan Berman

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leishmaniasis, Cutaneous

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model 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).
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
    Intervention Type
    Drug
    Intervention Name(s)
    miltefosine plus intralesional pentamidine
    Intervention Description
    miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
    Primary Outcome Measure Information:
    Title
    Lesion size
    Description
    area of lesion
    Time Frame
    6 months post therapy
    Secondary Outcome Measure Information:
    Title
    adverse effects at site
    Description
    pain, erythema, edema
    Time Frame
    days 1, 3, 5 of therapy
    Title
    systemic adverse effects
    Description
    gastrointestinal side effects
    Time Frame
    days 1 to 28 of therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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:

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Miltefosine Plus IL Pentamidine for Bolivian CL

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