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

University of Brasilia

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Leishmaniasis, Mucocutaneous; Leishmaniasis; Brazilian

Treatments: Drug: Pentoxifylline 400mg; Drug: Liposomal Amphotericin B; Drug: Miltefosine 50mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06040489

57768421.0.0000.5558

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis

Experimental group

Treatment:

Drug: Miltefosine 50mg

Drug: Pentoxifylline 400mg

Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis

Experimental group

Treatment:

Drug: Miltefosine 50mg

Drug: Pentoxifylline 400mg

Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis

Active Comparator group

Treatment:

Drug: Liposomal Amphotericin B

Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis

Active Comparator group

Treatment:

Drug: Liposomal Amphotericin B