Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Condition: Mucocutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Mucocutaneous
Study type: Observational

Summary: 
      This study is a Phase 4, open-label, single group study in which at least 40 adult patients
      undergoing miltefosine treatment for mucocutaneous leishmaniasis (CL and ML) will be assessed
      by 12-lead ECG for prolongation of the corrected QT interval
    

Detailed description: 
      This study is a Phase 4, open-label, single group study in which at least 40 adult patients
      undergoing miltefosine treatment for mucocutaneous leishmaniasis will be assessed by digital
      12-lead electrocardiogram (ECG) for prolongation of the corrected QT (QTc) interval.
      Potential subjects diagnosed with mucocutaneous leishmaniasis who are planning to undergo
      miltefosine treatment will be informed about the study and undergo the informed consent
      process. After obtaining informed consent, subjects will be screened over a 14-day period for
      eligibility by medical history including leishmaniasis diagnostics, physical examination,
      clinical laboratory measurements [chemistries: alanine aminotransferase (ALT), total
      bilirubin, creatinine, magnesium, calcium, potassium, sodium; hematology: white blood cell
      (WBC) count, hemoglobin, platelet count; and a pregnancy test if female], ECG, and medication
      use in the 28-day period before starting treatment. If eligible for the study, the subject
      will receive miltefosine for 28 days at a target dose of approximately 2.5 mg/kg/day.
      Screening and enrollment into the study will continue until at least 10 females and up to 30
      males complete the study and are considered evaluable (provide Day 28 ECGs and
      pharmacokinetic (PK) samples and complete at least 25 of 28 days of miltefosine treatment).
      Vital signs will be collected weekly during treatment. Chemistries and hematology will be
      repeated at study Days 14 (mid-treatment) and 28 (end of treatment). A pregnancy test (if
      applicable) will be repeated at Day 28. ECGs (12-lead) will be repeated at Days 14 and 28.
      Blood will be drawn for PK assessments on Days 14 and 28 within 15 minutes of the final ECG.
      Adverse events (AEs) and concomitant medication use will be collected during treatment. If on
      Day 28, clinically significant abnormalities are observed by ECG, then a repeat ECG and PK
      blood draw will be performed at Day 42 (2 weeks after completing treatment). AEs and
      concomitant medication use will also be collected in any subject coming back for the Day 42
      visit. Digital ECGs (12-lead) will be collected in triplicate at each time point over a
      period not to exceed 1 hour. During treatment, ECGs will be collected 4 hours after a dose
      (approximate Tmax).
    

Intervention name(s): Miltefosine
Intervention type(s): Drug
Other intervention name(s): Impavido
Intervention MeSH terms: Miltefosine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with mucocutaneous leishmaniasis being treated with miltefosine
      
Keywords: leishmaniasis; miltefosine; EKG