Mucosal Leishmaniasis
Conditions
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 controlled pharmacodynamic data, and additional considerations of administrative convenience (oral \>\>IV) and cost, we hope that it will be possible for policy makers, treatment professionals, and patients to choose the most appropriate therapy for ML.
Interventions
DRUGGroup 1: Miltefosine
Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
DRUGGroup 2: Pentavalent Antimony
will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
DRUGGroup 3: Liposomal amphotericin B
3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.
Sponsors
Hospital Dermatologico de Jorochito
Centro Nacional de Enfermedades Tropicales CENETROP
ABF Foundation for Medical Research
Fundacion Nacional de Dermatologia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Because of the disparate routes of administration, the study will not be blinded for the patients or clinical team. However, the ENT doctor who provides data to calculate the primary endpoint, the mucosal severity score, will be blinded.
Intervention model description
The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. A secondary purpose is to determine the tolerance of these regimens. Patients will be randomized between: Group 1---40 patients. Oral miltefosine. Group 2---40 patients. Intravenous pentavalent antimony (Glucantime) Group 3---40 patients. Intravenous liposomal amphotericin B (Ambisome) Because of the disparate routes of administration, the study will not be blinded for the patients or clinical team. However, the ENT doctor who provides data to calculate the primary endpoint, the mucosal severity score, will be blinded. After treatment, all patients will be followed for 2, 6, 9, and 12 months after the beginning of therapy. In addition, all attempts will be made to effect follow-up at 24 months.
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing of mucosal lesions | Baseline to 12 month follow up | The primary purpose is to perform a controlled evaluation of the cure rate of miltefosine, LAMB, and Sb for L braziliensis ML in Bolivia. Using a standarized scale we'll qualify from 0 (absent) to 3 (severe) the following items: erythema, edema/swelling, infiltration, erosion/ulceration, in five different places: nasal and perinasal skin, nasal mucosa, palate and oral mucosa, pharynx and larynx. Additionally, changes in voice quality will be registered. 63 will be the maximun score and means severe and massive compromise. clinical cure: \>90% loss of presenting severity score clinical improvement: 50%-90% loss of presenting severity score no clinical change: 25% worsening to 49% improvement in presenting severity score clinically worse: \>25% worsening of presenting score or relapse after initial improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and laboratory safety of these 3 drugs | Base line to 1 month after the end of therapy | The secondary purpose is to determine the tolerance of these regimens. Descriptive statistics will be used to present adverse event data. Continuous variables will be presented as number of observations (n), mean, standard deviation (SD), median, minimum and maximum values. Categorical variables will be presented as counts and percentages. Adverse effects will be compared between groups by appropriate statistics. During treatment administration clinical symptoms (nausea/vomit/abdominal pain; myalgias/arthralgias; headache/dizziness) and laboratory (AST, alkaline phosphatase, lipase, creatinine, CBC) and EKG (in patients receiving antomony) will be evaluated. |
Countries
Bolivia
Contacts
Primary Contactjaime soto, MD
Backup ContactPaula Soto, MD
Outcome results
None listed