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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

Primary Purpose

Leishmaniasis

Status
Active
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Meglumine antimoniate
Miltefosine
Pentoxifylline
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leishmaniasis focused on measuring Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis;
  • For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
  • Ages between 18 and 80 years old;
  • Fertile female patients should use at least two contraceptive methods (hormonal and barrier);
  • Agree to participate in the study and sign the informed consent term.

Exclusion Criteria:

  • Use of any leishmanicidal drugs six months prior;
  • Clinical or laboratorial evidences of electrocardiographic disorders;
  • Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
  • Hypersensitivity to meglucamine antimoniate;
  • Pregnancy or lactation;
  • Fertile females that do not agree to use contraceptive methods;
  • Patients that do not agree to the informed consent term.

Sites / Locations

  • Hospital Universitário de Brasília

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1 - Mucosal Antimoniate and Pentoxifylline

Group 2 - Mucosal Miltefosine and Pentoxifylline

Group 3 - Cutaneous Antimoniate and Pentoxifylline

Group 4 - Cutaneous Miltefosine and Pentoxifylline

Arm Description

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.

Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.

20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.

Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.

Outcomes

Primary Outcome Measures

Cure
Complete healing of previous lesions until the 90th day after the begin of the treatment
Failure
Lesions fail to heal until the 90th day after the begin of the treatment
Relapse
Lesions that reappear on the scar of a previously healed lesion

Secondary Outcome Measures

Full Information

First Posted
August 19, 2015
Last Updated
May 23, 2022
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT02530697
Brief Title
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
Official Title
The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia

4. Oversight

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

5. Study Description

Brief Summary
Mucocutaneous leishmaniasis is endemic in the central region of Brazil and other countries worldwide. The standard treatment with meglumine antimoniate has a high rate of important adverse effects. This interventional study consists in a randomized clinical trial to access efficacy and safety of the association of miltefosine and pentoxifylline compared to meglumine antimoniate and pentoxifyline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis
Keywords
Leishmaniasis, Mucocutaneous, Miltefosine, Pentoxifylline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - Mucosal Antimoniate and Pentoxifylline
Arm Type
Active Comparator
Arm Description
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days. Pentoxifylline 400mg 3x/daily for 28 days.
Arm Title
Group 2 - Mucosal Miltefosine and Pentoxifylline
Arm Type
Experimental
Arm Description
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily. Oral Pentoxifylline 400mg 3x/daily for 28 days.
Arm Title
Group 3 - Cutaneous Antimoniate and Pentoxifylline
Arm Type
Experimental
Arm Description
20mgSb+5/kg/day meglumine antimoniate intravenous for 20 days Oral Pentoxifylline 400mg 3x/daily for 20 days.
Arm Title
Group 4 - Cutaneous Miltefosine and Pentoxifylline
Arm Type
Experimental
Arm Description
Oral Miltefosine 2,5mg/kg/day up to 50mg 2x/daily Oral Pentoxifylline 400mg 3x/daily for 20 days.
Intervention Type
Drug
Intervention Name(s)
Meglumine antimoniate
Intervention Description
20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
Intervention Type
Drug
Intervention Name(s)
Miltefosine
Other Intervention Name(s)
Miltefosnine
Intervention Description
Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Intervention Description
Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
Primary Outcome Measure Information:
Title
Cure
Description
Complete healing of previous lesions until the 90th day after the begin of the treatment
Time Frame
90 days
Title
Failure
Description
Lesions fail to heal until the 90th day after the begin of the treatment
Time Frame
90 days
Title
Relapse
Description
Lesions that reappear on the scar of a previously healed lesion
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any treatment to leishmaniasis; For patients with cutaneous lesions: duration of disease longer then a 1 month and shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm; Ages between 18 and 80 years old; Fertile female patients should use at least two contraceptive methods (hormonal and barrier); Agree to participate in the study and sign the informed consent term. Exclusion Criteria: Use of any leishmanicidal drugs six months prior; Clinical or laboratorial evidences of electrocardiographic disorders; Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS; Hypersensitivity to meglucamine antimoniate; Pregnancy or lactation; Fertile females that do not agree to use contraceptive methods; Patients that do not agree to the informed consent term.
Facility Information:
Facility Name
Hospital Universitário de Brasília
City
Brasília
State/Province
DF
ZIP/Postal Code
70.840-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil

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