Treatment of Mucosal Bolivian Leishmaniasis
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|ClinicalTrials.gov Identifier: NCT04799236|
Recruitment Status : Not yet recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mucosal Leishmaniasis||Drug: Group 1: Miltefosine Drug: Group 2: Pentavalent Antimony Drug: Group 3: Liposomal amphotericin B||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|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.
|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.|
|Official Title:||Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B|
|Estimated Study Start Date :||April 1, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||November 30, 2023|
Active Comparator: Group 1: Oral Miltefosine
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.
Drug: Group 1: Miltefosine
Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
Active Comparator: Group 2: Intravenous pentavalent antimony
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
Drug: Group 2: Pentavalent Antimony
will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
Experimental: Group 3: Intravenous liposomal amphotericin B
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  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.
Drug: Group 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.
- Healing of mucosal lesions [ Time Frame: 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
- Clinical and laboratory safety of these 3 drugs [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04799236
|Contact: jaime soto, MDemail@example.com|
|Contact: Paula Soto, MDfirstname.lastname@example.org|