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

September 13, 2023 updated by: University of Brasilia
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • DF
      • Brasilia, DF, Brazil, 70840-901
        • Recruiting
        • Hospital Universitario de Brasilia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
Drug: Miltefosine 50mg
Oral Miltefosine 50mg bid
Drug: Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Experimental: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
Drug: Miltefosine 50mg
Oral Miltefosine 50mg bid
Drug: Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Active Comparator: Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
Drug: Liposomal Amphotericin B
Intravenous 25 to 40mg/kg
Active Comparator: Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis
Drug: Liposomal Amphotericin B
Intravenous 25 to 40mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure
Time Frame: 90 days after the begin of treatment
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
90 days after the begin of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 30 days after drug interruption
Presence laboratorial or clinica changes during treatment that lead to treatment interruption
30 days after drug interruption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 57768421.0.0000.5558

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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