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

Phase 2

Recruiting

• Conditions: Leishmaniasis; Brazilian; Leishmaniasis, Mucocutaneous
• Interventions: Drug: Miltefosine 50mg; Drug: Liposomal Amphotericin B; Drug: Pentoxifylline 400mg

• Registration Number: NCT06040489
• Lead Sponsor: University of Brasilia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-22
• Study First Submitted: 2022-11-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-09-13
• Last Update Submitted: 2023-09-13
• Study First Posted: 2023-09-15
• Last Update Posted: 2023-09-15
• Primary Completion: 2024-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis	Pentoxifylline 400mg	-
Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis	Miltefosine 50mg	-
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis	Miltefosine 50mg	-
Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis	Pentoxifylline 400mg	-
Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis	Liposomal Amphotericin B	-
Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis	Liposomal Amphotericin B	-

Primary Outcome Measures

Name	Time	Method
Cure	90 days after the begin of treatment	Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)

Secondary Outcome Measures

Name	Time	Method
Adverse effects	30 days after drug interruption	Presence laboratorial or clinica changes during treatment that lead to treatment interruption

Trial Locations

Locations (1)

Hospital Universitario de Brasilia; 🇧🇷 Brasilia, DF, Brazil