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| Name | Class |
|---|---|
| Hospital Dermatologico de Jorochito | UNKNOWN |
| Centro Nacional de Enfermedades Tropicales CENETROP | UNKNOWN |
| ABF Foundation for Medical Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Oral Miltefosine | Active Comparator | 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. |
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| Group 2: Intravenous pentavalent antimony | Active Comparator | 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 |
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| Group 3: Intravenous liposomal amphotericin B | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1: Miltefosine | Drug | Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Healing of mucosal lesions | 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 | Baseline to 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and laboratory safety of these 3 drugs | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jaime soto, MD | Contact | +59175648894 | jasm.dlb@gmail.com | |
| Paula Soto, MD | Contact | +59175648893 | dra.paula.dermalaser@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dermatologico de Jorochito | Recruiting | Santa Cruz de la Sierra | SC | 00000 | Bolivia |
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| ID | Term |
|---|---|
| D007897 | Leishmaniasis, Mucocutaneous |
| ID | Term |
|---|---|
| D016773 | Leishmaniasis, Cutaneous |
| D007896 | Leishmaniasis |
| D056986 | Euglenozoa Infections |
| D011528 | Protozoan Infections |
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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.
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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.
| Group 2: Pentavalent Antimony | Drug | will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes |
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| Group 3: Liposomal amphotericin B | Drug | 3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses. |
|
| Base line to 1 month after the end of therapy |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D012876 | Skin Diseases, Parasitic |
| D000079426 | Vector Borne Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |