Actively Recruiting

Phase 2
Phase 3
Age: 50Years +
All Genders
NCT06040489

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

Led by University of Brasilia · Updated on 2023-09-15

100

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Active confirmed cutaneous leishmaniasis or mucosal leishmaniasis
  • Use of highly effective contraceptive method and a negative pregnancy test if female in fertile phase
  • Agree and sign informed consent form
Not Eligible

You will not qualify if you...

  • Previous treatment with leishmanicidal drugs in the last 6 months
  • Electrocardiographic changes contraindicating liposomal amphotericin B (QTc > 450ms)
  • Serum creatinine or urea 1.5 times above normal limit
  • Severe or decompensated liver, kidney, heart disease, or diabetes mellitus
  • History of hypersensitivity to liposomal amphotericin B, miltefosine, or pentoxifylline
  • Pregnant or breastfeeding women
  • Patients with AIDS or other immunodeficiency

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hospital Universitario de Brasilia

Brasília, Federal District, Brazil, 70840-901

Actively Recruiting

Loading map...

Research Team

R

Raimunda Sampaio, PhD

CONTACT

S

Sofia Martins, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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