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

Launched by FUNDACION NACIONAL DE DERMATOLOGIA · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for a condition called mucosal leishmaniasis, which affects the nose and throat and is caused by a parasite. Researchers are looking at how well a combination of inhaled pentamidine and oral miltefosine works to help patients with this condition. The trial is currently recruiting participants who are over 12 years old, weigh more than 45 kilograms, and have a confirmed diagnosis of mucosal leishmaniasis.

To participate, individuals must not have received certain treatments for leishmaniasis in the last year and should be in good overall health. If eligible, participants will receive the study medications and will be monitored closely by medical professionals throughout the trial. It's important for women of childbearing age to use effective contraception during and after the treatment period. This study aims to find a better way to treat this challenging condition, potentially improving the health and quality of life for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.