Comparing treatments for mucosal leishmaniasis
Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B
This study is testing three different treatments for mucosal leishmaniasis to see which one works best and has the fewest side effects for patients.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Sponsor | Fundacion Nacional de Dermatologia Academic / other |
| Locations | 1 site (Santa Cruz de la Sierra, SC) |
| Trial ID | NCT04799236 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and tolerance of three treatments for mucosal leishmaniasis: miltefosine, pentavalent antimony, and liposomal amphotericin B. Participants will be randomly assigned to one of the treatment groups, and the study will assess both the effectiveness of the treatments and their side effects. The goal is to provide data that can help healthcare providers and patients choose the most suitable therapy based on efficacy, convenience, and cost.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals over 45 kg with confirmed mucosal leishmaniasis.
Not a fit: Patients who have received treatment for leishmaniasis in the past 12 months or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and accessible treatment options for patients suffering from mucosal leishmaniasis.
How similar studies have performed: Other studies have explored treatments for leishmaniasis, but this specific comparison of these three therapies is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * weight over 45 kg * Parasitological confirmation of the lesion will be made by visualization of Leishmania, culture of Leishmania, or molecular identification of Leishmania (PCR) from the biopsy or aspirate of the lesion. Exclusion Criteria: * Previous treatment for leishmaniasis in the last 12 months * concomitant diseases by history that would be likely in the PI's opinion to interact, either positively or negatively, with treatment * values of complete blood count, liver function (aspartate aminotransferase, alkaline phosphatase), renal function (creatinine), pancreatic function (lipase), or uric acid beyond 1.5 x normal range * EKG with clinically significant abnormalities * Women of childbearing age not agreeing with the use of secure reproductive contraception for 4 months after initiating miltefosine therapy.
Where this trial is running
Santa Cruz de la Sierra, SC
- Hospital Dermatologico de Jorochito — Santa Cruz de la Sierra, Sc, Bolivia (Recruiting)
Study contacts
- Study coordinator: jaime soto, MD
- Email: jasm.dlb@gmail.com
- Phone: +59175648894
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.