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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01437020
Eligibility Criteria:
* INCLUSION CRITERIA:
Subjects (18 to 60 years of age) who meet the following criteria are eligible to enter the study:
* Newly diagnosed VL (within 4 to 5 days of screening) and confirmed by spleen or bone marrow aspirate.
* Clinical signs and symptoms compatible with VL: fever (\> 99 degrees F) over a 2-week duration, splenomegaly (palpable spleen below the costal margin), and weight loss.
* Biochemical and hematological test values:
Hemoglobin \> 6.0g/100mL.
WBC count \> 1.0 times 10(9)/L.
Platelet count \> 40 times 10(9)/L.
Aspartate aminotransferase (AST),alanine transaminase (ALT), and alkaline phosphatase \< 3 times the upper limit of normal.
Prothrombin time (PT) \< 4 seconds above the control values.
Serum creatinine levels within normal limits (males, 0.7 mg/dL - 1.1 mg/dL; females, 0.6 mg/dL - 0.9 mg/dL).
* Human immunodeficiency virus (HIV)-negative status.
* Willingness to be hospitalized for 30 days.
* Willingness to have samples stored.
* Negative serum pregnancy test result for women of childbearing potential.
EXCLUSION CRITERIA:
* A history of intercurrent or concurrent diseases (e.g., chronic alcohol consumption or drug addiction; renal, hepatic, cardiovascular, or central nervous system disease; diabetes; tuberculosis or other infectious or major psychiatric diseases) that may introduce variables affecting the outcome of the study.
* Any condition which, in the investigator's opinion, may prevent the subject from completing the study and the subsequent follow-up.
* Previous treatment for VL within 45 days of study enrollment.
* A history of allergy or hypersensitivity to amphotericin B.
* Prior treatment failures with amphotericin B.
* Current use of other drugs with known anti-leishmanial activity (e.g., antimonials, pentamidine, paromomycin, miltefosine), azoles (e.g., fluconazole, ketoconazole or itraconazole), nephrotoxic drugs, immunosuppressive drugs, other investigational agents, immunomodulatory drugs.
* Breastfeeding women
* Vaccinations within 30 days prior to enrollment in the study.
Exclusion of children:
Subjects younger than 18 years of age will be excluded from the study because insufficient data are available supporting dosing with SCH708980 in adults to judge the potential risk in children.
Exclusion of women:
Pregnant and lactating women are excluded from the study because insufficient data are available supporting dosing with SCH708980 in these populations to judge the potential risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01437020
Study Brief:
Protocol Section:
NCT01437020