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RecruitingPhase 2NCT06550609

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

Sponsor

Fundacion Nacional de Dermatologia

Enrollment

30 participants

Start Date

Feb 4, 2025

Study Type

INTERVENTIONAL

Conditions

Mucosal Leishmaniasis

Summary

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

Eligibility

Min Age: 12 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

DRUGMiltefosine Oral Capsule

Miltefosine 3 pill per day during 28 days AND pentamidine inhaled 300 mg / d during 10 dosis

Locations(1)

Hospital de Clinicas

La Paz, La Paz Department, Bolivia

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NCT06550609