NCT02530697

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started Aug 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2015Aug 2026

Study Start

First participant enrolled

August 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

10 years

First QC Date

August 19, 2015

Last Update Submit

January 11, 2024

Conditions

Leishmaniasis

Keywords

LeishmaniasisMucocutaneousMiltefosinePentoxifylline

Outcome Measures

Primary Outcomes (3)

  • Cure

    Complete healing of previous lesions until the 90th day after the begin of the treatment

    90 days

  • Failure

    Lesions fail to heal until the 90th day after the begin of the treatment

    90 days

  • Relapse

    Lesions that reappear on the scar of a previously healed lesion

    90 days

Study Arms (4)

Group 1 - Mucosal Antimoniate and Pentoxifylline

ACTIVE COMPARATOR

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

Drug: Meglumine antimoniateDrug: Pentoxifylline

Group 2 - Mucosal Miltefosine and Pentoxifylline

EXPERIMENTAL

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

Drug: MiltefosineDrug: Pentoxifylline

Group 3 - Cutaneous Antimoniate and Pentoxifylline

EXPERIMENTAL

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

Drug: Meglumine antimoniateDrug: Pentoxifylline

Group 4 - Cutaneous Miltefosine and Pentoxifylline

EXPERIMENTAL

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

Drug: MiltefosineDrug: Pentoxifylline

Interventions

Meglumine antimoniateDRUG

20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.

Group 1 - Mucosal Antimoniate and PentoxifyllineGroup 3 - Cutaneous Antimoniate and Pentoxifylline
MiltefosineDRUG

Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.

Also known as: Miltefosnine
Group 2 - Mucosal Miltefosine and PentoxifyllineGroup 4 - Cutaneous Miltefosine and Pentoxifylline
PentoxifyllineDRUG

Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.

Group 1 - Mucosal Antimoniate and PentoxifyllineGroup 2 - Mucosal Miltefosine and PentoxifyllineGroup 3 - Cutaneous Antimoniate and PentoxifyllineGroup 4 - Cutaneous Miltefosine and Pentoxifylline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário de Brasília

Brasília, Federal District, 70.840-901, Brazil

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

Meglumine AntimoniatemiltefosinePentoxifylline

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MeglumineSorbitolSugar AlcoholsAlcoholsOrganic ChemicalsHexosaminesAmino SugarsCarbohydratesTheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 21, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

January 16, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)