Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Hospital de Clinicas
La Paz, La Paz Department, Bolivia, 00000
Actively Recruiting
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
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