NCT02429518

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

September 4, 2020

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

April 22, 2015

Last Update Submit

September 2, 2020

Conditions

Mucocutaneous Leishmaniasis

Keywords

leishmaniasismiltefosineEKG

Outcome Measures

Primary Outcomes (1)

  • mean value of corrected QT interval

    QTcF

    up to 2 weeks after end of treatment

Secondary Outcomes (1)

  • number of patients with adverse events

    up to 2 months after end of treatment

Study Arms (1)

Miltefosine

Miltefosine: target of 2.5 mg/kg/day for 28 days

Drug: Miltefosine

Interventions

MiltefosineDRUG
Also known as: Impavido
Miltefosine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Persons with mucocutaneous leishmaniasis being treated with miltefosine

You may qualify if:

  • Provide written informed consent
  • Be available to complete study procedures
  • Have a diagnosis of mucocutaneous leishmaniasis confirmed by microscopy of a stained smear of a lesion sample, by culture of a lesion sample, or by polymerase chain reaction (PCR) of a lesion sample or by Montenegro skin test and be willing to undergo treatment with miltefosine
  • Be male or female and 18-55 years of age
  • Have alanine aminotransferase (ALT), total bilirubin, and creatinine \< 1.5 x upper upper limit of normal (ULN)
  • Have white blood cell (WBC) count, hemoglobin, and platelet count within 15% of within normal limits (WNL)
  • Be without clinically significant non-cardiac medical disorder
  • Have 12-lead corrected QT interval using the Fridericia method (QTcF) interval \< 450 msec, abnormal heart rate (\< 40 or \> 120 beats/min), PR interval (from 131 msec to 197 msec for males and 120 msec to 196 msec for females, or QRS interval (from 78 msec to 126 msec for males and 74 msec to 114 msec for females)
  • Have blood levels of ions that might affect ECG: (magnesium 1.82 mg/dL to 2.41 mg/dL, calcium 8.5 mg/dL to 10.5 mg/dL, potassium 3.5 milliequivalents/liter (mEq/L) to 10.5 mEq/L, and sodium 135 mEq/L to 148 mEq/L)
  • Have no family history of sudden cardiac death before age 40
  • Have no personal history ischemic heart disease, congestive heart failure, palpitations, dizziness, syncope, cardiac arrhythmias
  • If female, agree to use an effective method of birth control from the start of treatment until 5 months after completing treatment and have a negative pregnancy test

You may not qualify if:

  • Be a female who is breast feeding
  • Be a female who is pregnant
  • In the past 28 days prior to the start of miltefosine treatment have received any drug or other treatment that is known to significantly affect the QTc interval
  • Have positive serology for Chagas disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Funderma

Santa Cruz, Bolivia

Location

MeSH Terms

Conditions

Leishmaniasis, MucocutaneousLeishmaniasis

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Leishmaniasis, CutaneousEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jaime Soto, MD

    Fundacion Nacional de Dermatologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2015

First Posted

April 29, 2015

Study Start

December 1, 2015

Primary Completion

June 6, 2017

Study Completion

March 6, 2018

Last Updated

September 4, 2020

Record last verified: 2019-03

Locations

BO(1)