Actively Recruiting

Phase 2
Age: 12Years +
All Genders
NCT06550609

Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine

Led by Fundacion Nacional de Dermatologia · Updated on 2025-02-26

30

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.

CONDITIONS

Official Title

Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female gender
  • Age greater than 12 years
  • Weight over 45 kilograms
  • Provided consent before any study procedures
  • Mucosal disease involving nares, nasal mucosa, palate, pharynx, or larynx confirmed by an ENT specialist
  • Parasitological confirmation of lesion by Leishmania visualization, culture, PCR, or positive Leishmanin skin test plus characteristic scar and epidemiologic history
Not Eligible

You will not qualify if you...

  • Prior treatment for leishmaniasis with specific therapies in the last 12 months
  • Previous treatment with miltefosine or pentamidine allowed only if ended more than 12 months ago and disease stable for 6 months
  • Medical history of other diseases that may interfere with treatment
  • Laboratory test values exceeding 1.5 times normal range for blood count, liver, kidney, pancreas, or uric acid considered clinically significant
  • Clinically significant abnormalities on electrocardiogram
  • Women of childbearing potential must use effective contraception or abstinence for 5 months after starting therapy

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 de Clinicas

La Paz, La Paz Department, Bolivia, 00000

Actively Recruiting

Loading map...

Research Team

J

jaime soto, MD

CONTACT

P

Paula Soto, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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