Phase 2 Study of Inhaled Pentamidine and Oral Miltefosine for Treating Bolivian Mucosal Leishmaniasis

What this Trial Is About

Researchers are evaluating the combination of inhaled pentamidine and oral miltefosine as a treatment for mucosal leishmaniasis caused by Leishmania braziliensis in Bolivia. Mucosal leishmaniasis is a severe form of the disease that damages the nose, throat, and related areas and is difficult to cure with traditional treatments. This phase 2 study aims to improve cure rates, especially for moderate to severe cases, by using a non-intravenous drug combination. Participants will receive oral miltefosine three times daily for 28 days and inhaled pentamidine at 300 mg on specific days 1, 3, 5, 8, 10, 12, 15, 17, 19, and 22. The study plans to enroll 20 patients with moderate to severe disease and up to 10 patients with milder cases. This combination therapy is fully non-parenteral and is expected to minimize overlapping side effects. During the study, researchers will monitor patients for effectiveness of the treatment over 25 months and track any treatment-emergent side effects for 6 months. Patients will undergo evaluations by ENT specialists and parasitological confirmation tests before enrollment. The study includes safety assessments such as blood tests, liver and kidney function monitoring, and heart evaluations. Participants will be followed throughout the treatment and for an extended period to assess cure and safety outcomes.

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