Treatment of Mucosal Bolivian Leishmaniasis
Mucosal Leishmaniasis
About this trial
This is an interventional treatment trial for Mucosal Leishmaniasis
Eligibility 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.
Sites / Locations
- Hospital Dermatologico de JorochitoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Group 1: Oral Miltefosine
Group 2: Intravenous pentavalent antimony
Group 3: Intravenous liposomal amphotericin B
Miltefosine will be administered per os at 150 mg/day [50 mg tid] for 28 days. This is the standard regimen of miltefosine for persons >45 kg.
IV pentavalent antimony (meglumine antimoniate) will be administrated at 20 mg x kg x d during 20 consecutive days. Antimony will be diluted in 10 times its volume in 5%Dextrose in destilled water and injected IV in 20 minutes
LAMB will be administered IV at 3 ampules [150 mg] on each of days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27. Three ampules is the individual dose suggested by Aronson et al [2016] and equals 2.5 mg/kg/dose for a 60 kg person. 15 doses of 3 ampules (total of 2250 mg) equals 37.5 mg/kg for a 60 kg person.