Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishman… (NCT02429518) | Clinical Trial Compass
CompletedNot Applicable
Dedicated QT Study in Bolivian Patients Taking Impavido® (Miltefosine) for Mucocutaneous Leishmaniasis
Bolivia42 participantsStarted 2015-12
Plain-language 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
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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)
Exclusion criteria
. Be a female who is breast feeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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