Status:
RECRUITING
Treatment of Mucosal Bolivian Leishmaniasis
Lead Sponsor:
Fundacion Nacional de Dermatologia
Collaborating Sponsors:
Hospital Dermatologico de Jorochito
Centro Nacional de Enfermedades Tropicales CENETROP
Conditions:
Mucosal Leishmaniasis
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
Brief Summary
The purpose of this protocol is to conduct a randomized comparison of the efficacy and tolerance of miltefosine, LAMB, and pentavalent antimony for the treatment of mucosal leishmaniasis. With such co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04799236
Start Date
April 1 2021
End Date
November 30 2024
Last Update
March 5 2024
Active Locations (1)
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1
Hospital Dermatologico de Jorochito
Santa Cruz de la Sierra, SC, Bolivia, 00000