Status:
RECRUITING
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis with Inhaled Pentamidine Plus Oral Miltefosine
Lead Sponsor:
Fundacion Nacional de Dermatologia
Conditions:
Mucosal Leishmaniasis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis.
Detailed Description
The 3 major forms of leishmaniasis are visceral, cutaneous, and mucosal disease. Of these, mucosal leishmaniasis (ML) arguably poses the most difficult therapeutic problem. Although visceral disease (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Previous treatment for leishmaniasis: No specific or putatively specific therapy (Sb, pentamidine, amphotericin B, miltefosine, imidazoles, allopurinol) in the last 12 months. Patients may have been previously treated with the agents under investigation---miltefosine, pentamidine---if that treatment ended more than 12 months ago and the disease has not diminished in the last 6 months.
- Other diseases: Concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment.
- Laboratory : Values of complete blood count, liver function (AST, ALT, alkaline phosphatase), renal function (creatinine, BUN), pancreatic function (lipase), or uric acid beyond 1.5 x Normal Range and that in the PI's opinion would be clinically meaningful.
- EKG: Clinically significant abnormalities.
- Contraception: Women of childbearing age are required to practice reproductive contraception for 5 months after initiating therapy: abstinence or effective contraception defined as 2 forms of contraception \[a barrier method (diaphragm, condom, or cervical cap with spermicidal foam, gel, or cream) plus a 2nd barrier method or hormonal contraceptive or intrauterine device\] from day 1 through 5 months post therapy.
Key Trial Info
Start Date :
February 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06550609
Start Date
February 4 2025
End Date
February 1 2028
Last Update
February 26 2025
Active Locations (1)
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1
Hospital de Clinicas
La Paz, La Paz Department, Bolivia, 00000