Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT02429518
Eligibility Criteria:
Inclusion Criteria:
1. Provide written informed consent
2. Be available to complete study procedures
3. 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
4. Be male or female and 18-55 years of age
5. Have alanine aminotransferase (ALT), total bilirubin, and creatinine \< 1.5 x upper upper limit of normal (ULN)
6. Have white blood cell (WBC) count, hemoglobin, and platelet count within 15% of within normal limits (WNL)
7. Be without clinically significant non-cardiac medical disorder
8. 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)
9. 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)
10. Have no family history of sudden cardiac death before age 40
11. Have no personal history ischemic heart disease, congestive heart failure, palpitations, dizziness, syncope, cardiac arrhythmias
12. 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
Exclusion Criteria:
1. Be a female who is breast feeding
2. Be a female who is pregnant
3. 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
4. Have positive serology for Chagas disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02429518
Study Brief:
Protocol Section:
NCT02429518