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:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT05613361
Eligibility Criteria:
Inclusion Criteria:
* All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy
Exclusion Criteria:
* Patients receiving intravenous colistin therapy for \< 72 hours.
* Patients receiving renal replacement therapy (RRT).
* Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.
* Pregnancy or breastfeeding.
* Known allergy to the study medications.
* Patients with chronic kidney diseases (creatinine clearance \< 60 mg/dL).
* Elevated total liver enzymes (AST, and ALT) three times above the upper limit of normal.
* Patients with acute decompensated heart failure signs and symptoms requiring intravenous loop diuretics and/or intravenous inotropes and/or ACE inhibitors.
* Uncontrolled diabetes (Glycosylated hemoglobin (Hb A1C) \>8%).
* Hypotensive patients defined as decrease in blood pressure less than 90/60 mm Hg.
* Recent use of vitamins with antioxidant properties such as beta carotene, vitamin E, vitamin C, selenium, or N-acetylcysteine or any other medications known to have nephroprotective activities.
* Patients receiving other nephrotoxic drugs at enrollment (e.g., aminoglycosides, vancomycin, or amphotericin B) or administration of contrast medium within 7 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05613361
Study Brief:
Protocol Section:
NCT05613361