Clinical trial NCT04799236: Treatment of Mucosal Bolivian Leishmaniasis
Official title: Treatment of Bolivian Mucosal Leishmaniasis With Miltefosine, Pentavalent Antimony or Liposomal Amphotericin B
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Mucosal Leishmaniasis
Lead sponsor: Fundacion Nacional de Dermatologia
Sponsor class: OTHER
Collaborators: name: Hospital Dermatologico de Jorochito
name: Centro Nacional de Enfermedades Tropicales CENETROP
name: ABF Foundation for Medical Research
First posted: 2021-03-16
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Healing of mucosal lesions
timeFrame: Baseline to 12 month follow up
Secondary outcomes:
measure: Clinical and laboratory safety of these 3 drugs
timeFrame: Base line to 1 month after the end of therapy
Other outcomes:
Locations:
city: Santa Cruz de la Sierra
country: Bolivia
facility: Hospital Dermatologico de Jorochito
state: SC
Study officials:
References: