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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
Sponsor:
Collaborators:
Hospital Dermatologico de Jorochito
Centro Nacional de Enfermedades Tropicales CENETROP
ABF Foundation for Medical Research
Information provided by (Responsible Party):
Fundacion Nacional de Dermatologia

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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: 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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Arm Intervention/treatment
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 [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.
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.




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: jaime soto, MD +59175648894 jasm.dlb@gmail.com
Contact: Paula Soto, MD +59175648893 dra.paula.dermalaser@gmail.com

Sponsors and Collaborators
Fundacion Nacional de Dermatologia
Hospital Dermatologico de Jorochito
Centro Nacional de Enfermedades Tropicales CENETROP
ABF Foundation for Medical Research
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Responsible Party: Fundacion Nacional de Dermatologia
ClinicalTrials.gov Identifier: NCT04799236    
Other Study ID Numbers: ABF-BO-2021-100
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
Amphotericin B
Liposomal amphotericin B
Miltefosine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antifungal Agents
Antineoplastic Agents