Treatment for Mucosal Leishmaniasis using Inhaled Pentamidine and Oral Miltefosine
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine
PHASE2 · Fundacion Nacional de Dermatologia · NCT06550609
This study is testing a new treatment that combines inhaled pentamidine and oral miltefosine to see if it can help people with a severe form of leishmaniasis called mucosal leishmaniasis feel better.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Fundacion Nacional de Dermatologia (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (La Paz, La Paz Department) |
| Trial ID | NCT06550609 on ClinicalTrials.gov |
What this trial studies
This phase 2 study investigates the effectiveness of a combined therapy using inhaled pentamidine and oral miltefosine for patients suffering from Bolivian mucosal leishmaniasis. Mucosal leishmaniasis is a severe form of the disease that can lead to significant erosion of facial structures and has a poor response to traditional treatments. The study aims to provide a more effective treatment option for this challenging condition by evaluating the outcomes of this novel combination therapy. Participants will be monitored for parasitological confirmation of their condition and overall treatment response.
Who should consider this trial
Good fit: Ideal candidates include individuals over 12 years old with confirmed mucosal leishmaniasis and no prior treatment for leishmaniasis in the last 12 months.
Not a fit: Patients who have received specific leishmaniasis therapies within the past year or those with other forms of leishmaniasis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates and quality of life for patients with mucosal leishmaniasis.
How similar studies have performed: While mucosal leishmaniasis has been difficult to treat, this approach is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Paz, La Paz Department
- Hospital de Clinicas — La Paz, La Paz Department, Bolivia (RECRUITING)
Study contacts
- Study coordinator: jaime soto, MD
- Email: Jasm.dlb@gmail.com
- Phone: 75648894
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mucosal Leishmaniasis, Leishmaniasis, Mucosal leishmaniasis, Miltefosine, Pentamidine, Combined therapy