Treatment of Mucosal Bolivian Leishmaniasis

Mucosal Leishmaniasis Clinical Trial

Official title:

Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799236
• Other study ID #: ABF-BO-2021-100
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Fundacion Nacional de Dermatologia
• Contact: jaime soto, MD
• Phone: +59175648894
• Email: jasm.dlb[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Mucocutaneous
• Mucosal Leishmaniasis

Intervention

Drug:
• Group 1: Miltefosine
Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
• Group 2: Pentavalent Antimony
will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
• 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.

Locations

Country	Name	City	State
Bolivia	Hospital Dermatologico de Jorochito	Santa Cruz de la Sierra	SC

Sponsors (4)

Lead Sponsor	Collaborator
Fundacion Nacional de Dermatologia	ABF Foundation for Medical Research, Centro Nacional de Enfermedades Tropicales CENETROP, Hospital Dermatologico de Jorochito

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Base line to 1 month after the end of therapy