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

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ClinicalTrials.gov Identifier: NCT06040489
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
University of Brasilia

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

Condition or disease Intervention/treatment Phase
Leishmaniasis; Brazilian Leishmaniasis, Mucocutaneous Drug: Miltefosine 50mg Drug: Pentoxifylline 400mg Drug: Liposomal Amphotericin B Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly
Actual Study Start Date : June 22, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis Drug: Miltefosine 50mg
Oral Miltefosine 50mg bid

Drug: Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Experimental: Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis Drug: Miltefosine 50mg
Oral Miltefosine 50mg bid

Drug: Pentoxifylline 400mg
Oral Pentoxifylline 400mg tid
Active Comparator: Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis Drug: Liposomal Amphotericin B
Intravenous 25 to 40mg/kg
Active Comparator: Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis Drug: Liposomal Amphotericin B
Intravenous 25 to 40mg/kg


Outcome Measures
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Primary Outcome Measures :
  1. Cure [ Time Frame: 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 :
  1. Adverse effects [ Time Frame: 30 days after drug interruption ]
    Presence laboratorial or clinica changes during treatment that lead to treatment interruption


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040489


Contacts
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Contact: Raimunda Sampaio, PhD +556120285415 rnrsampaio@hotmail.com
Contact: Sofia Martins, PhD +556120285415 sofiasalesm@gmail.com

Locations
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Brazil
Hospital Universitario de Brasilia Recruiting
Brasilia, DF, Brazil, 70840-901
Contact: Raimunda Sampaio, PhD    +556120285415    rnrsampaio@hotmail.com   
Sponsors and Collaborators
University of Brasilia
More Information
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Responsible Party: University of Brasilia
ClinicalTrials.gov Identifier: NCT06040489    
Other Study ID Numbers: 57768421.0.0000.5558
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Brasilia:
Elderly
Miltefosine
Leishmaniasis
 Pentoxifylline
Liposomal amphotericin b
Treatment
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Infections
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
Amphotericin B
Liposomal amphotericin B
Miltefosine
Pentoxifylline
 Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers
Antioxidants
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents