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

Leishmaniasis, Mucocutaneous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040489
• Other study ID #: 57768421.0.0000.5558
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 22, 2022
• Est. completion date: June 2026

Study information

• Verified date: August 2023
• Source: University of Brasilia
• Contact: Raimunda Sampaio, PhD
• Phone: +556120285415
• Email: rnrsampaio[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Mucocutaneous

Intervention

Drug:
• Miltefosine 50mg
Oral Miltefosine 50mg bid
• Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
• Liposomal Amphotericin B
Intravenous 25 to 40mg/kg

Locations

Country	Name	City	State
Brazil	Hospital Universitario de Brasilia	Brasilia	DF

Sponsors (1)

Lead Sponsor	Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure	Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)	90 days after the begin of treatment
Secondary	Adverse effects	Presence laboratorial or clinica changes during treatment that lead to treatment interruption	30 days after drug interruption