Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
1 other identifier
interventional
100
1 country
1
Brief Summary
Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2022
Typical duration for phase_2
1 active site
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 Start
First participant enrolled
June 22, 2022
CompletedFirst Submitted
Initial submission to the registry
November 28, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedSeptember 15, 2023
August 1, 2023
1.9 years
November 28, 2022
September 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure
Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)
90 days after the begin of treatment
Secondary Outcomes (1)
Adverse effects
30 days after drug interruption
Study Arms (4)
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis
EXPERIMENTALOral Miltefosine and Pentoxifylline for Mucous Leishmaniasis
EXPERIMENTALIntravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis
ACTIVE COMPARATORIntravenous Liposomal Amphotericin B for Mucous Leishmaniasis
ACTIVE COMPARATORInterventions
Oral Miltefosine 50mg bid
Oral Pentoxifylline 400mg tid
Intravenous 25 to 40mg/kg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario de Brasilia
BrasÃlia, Federal District, 70840-901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2022
First Posted
September 15, 2023
Study Start
June 22, 2022
Primary Completion
June 1, 2024
Study Completion (Estimated)
June 1, 2026
Last Updated
September 15, 2023
Record last verified: 2023-08