Image

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

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

Recruiting
50 years and older
All
Phase 2/3
  • Technical (Original)
  • Simplified (AI rewritten)

Powered by AI

Overview

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

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

Study details
    Leishmaniasis; Brazilian
    Leishmaniasis
    Mucocutaneous

NCT06040489

University of Brasilia

26 January 2024

Contact a study center
Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.