Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis with Inhaled Pentamidine Plus Oral Miltefosine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Gender: Male or female
• Age: \>12 yrs of age
• Weight: \> 45 kg
• Consent: Prior to any investigations
• Mucosal disease: Involvement of the nares, nasal mucosa, palate, pharynx, larynx according to the ENT specialist.
• Parasitology: Parasitological confirmation of the lesion (s) will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion (s); or a positive Leishmanin skin test plus a scar characteristic of cutaneous leishmaniasis, plus the epidemiologic antecedent of living now or in the past, in an endemic area.
Locations
Other Locations
Plurinational State of Bolivia
Hospital de Clinicas
RECRUITING
La Paz
Contact Information
Primary
jaime soto, MD
Jasm.dlb@gmail.com
75648894
Backup
Paula Soto, MD
dra.paula.dermalaser@gmail.com
75648893
Time Frame
Start Date: 2025-02-04
Estimated Completion Date: 2028-02
Participants
Target number of participants: 30
Treatments
Experimental: Subjects treated
Miltefosine TID for 28 days Inhaled pentamidine 300 mg on days 1,3,5,8,10,12,15,17,19,22
Related Therapeutic Areas
Sponsors
Leads: Fundacion Nacional de Dermatologia