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Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

Primary Purpose

Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Miltefosine 50mg
Pentoxifylline 400mg
Liposomal Amphotericin B
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leishmaniasis; Brazilian focused on measuring Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment

Eligibility Criteria

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

Inclusion Criteria: Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase Agree and sing informed consent form Exclusion Criteria: Previous treatment with leishmanicidal drugs in the last 6 months Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms) Serum creatinine or urea 1.5 times the upper limit of normal Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline Pregnant and breastfeeding women Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency

Sites / Locations

  • Hospital Universitario de BrasiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis

Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis

Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis

Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis

Arm Description

Outcomes

Primary Outcome Measures

Cure
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)

Secondary Outcome Measures

Adverse effects
Presence laboratorial or clinica changes during treatment that lead to treatment interruption

Full Information

First Posted
November 28, 2022
Last Updated
September 13, 2023
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT06040489
Brief Title
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Official Title
Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis; Brazilian, Leishmaniasis, Mucocutaneous
Keywords
Elderly, Miltefosine, Leishmaniasis, Pentoxifylline, Liposomal amphotericin b, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Arm Type
Experimental
Arm Title
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Arm Type
Experimental
Arm Title
Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
Arm Type
Active Comparator
Arm Title
Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Miltefosine 50mg
Intervention Description
Oral Miltefosine 50mg bid
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline 400mg
Intervention Description
Oral Pentoxifylline 400mg tid
Intervention Type
Drug
Intervention Name(s)
Liposomal Amphotericin B
Intervention Description
Intravenous 25 to 40mg/kg
Primary Outcome Measure Information:
Title
Cure
Description
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
Time Frame
90 days after the begin of treatment
Secondary Outcome Measure Information:
Title
Adverse effects
Description
Presence laboratorial or clinica changes during treatment that lead to treatment interruption
Time Frame
30 days after drug interruption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase Agree and sing informed consent form Exclusion Criteria: Previous treatment with leishmanicidal drugs in the last 6 months Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms) Serum creatinine or urea 1.5 times the upper limit of normal Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and/or pentoxifylline Pregnant and breastfeeding women Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raimunda Sampaio, PhD
Phone
+556120285415
Email
rnrsampaio@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Martins, PhD
Phone
+556120285415
Email
sofiasalesm@gmail.com
Facility Information:
Facility Name
Hospital Universitario de Brasilia
City
Brasilia
State/Province
DF
ZIP/Postal Code
70840-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raimunda Sampaio, PhD
Phone
+556120285415
Email
rnrsampaio@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly

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