Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients
18 Years
N/A
Both
Infection
Trial Information
Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients
The Study Drug:
Vancomycin is an antibiotic used to treat serious, life-threatening infections caused by
bacteria. Researchers want to find the best and most effective dose and blood-level of the
drug that may have the best effect against bacteria.
Study Drug Administration:
If your doctor believes you are eligible, and you agree to take part in this study, you will
be given a "loading dose" of vancomycin that is about twice as large as the standard dose.
The dose amounts will be based on your body weight. Doses can be given every 8-12 hours,
depending on your level of kidney function.
Study Procedures:
Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing and to
check your kidney function. PK testing measures the amount of study drug in the body at
different time points. PK blood samples will be drawn just after the loading dose, and then
just before each standard dose of vancomycin (up to 5 samples total). When possible, the PK
sample may be drawn through a central venous catheter or line you already have placed, to
avoid extra "needle sticks."
The study staff will collect information about your health and any side effects you may be
having for 7 days.
Length of Study:
Treatment with vancomycin may be stopped early if you experience intolerable side effects or
the doctor thinks you can stop taking the drug early.
This is an investigational study. Vancomycin is FDA approved and commercially available for
use in treating bacterial infection. The use of a loading dose for vancomycin is
investigational.
Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.
Inclusion Criteria:
1. Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the
Thoracic Surgery physician group
2. Intravenous vancomycin therapy deemed necessary
Exclusion Criteria:
1. Age less than 18 years
2. History of hypersensitivity to vancomycin
3. Patient weight greater than 150 kg
4. Receival of 1 or more doses of the following agents within 72 hours prior to
screening: amphotericin B (lipid, liposomal, or conventional formulation),
aminoglycosides, foscarnet and/or intravenous contrast dye.
5. Prior exposure (within 7 days) to intravenous vancomycin
6. Current renal insufficiency defined as baseline Scr >/= 1.5 mg/dL, or increase in
baseline serum creatinine (SCr) by >/= 0.5 mg/dL within the last 2 days, or estimated
creatinine clearance (CrCl)
7. Current need for hemodialysis or continuous renal replacement therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose
Outcome Description:
Peak level (PK blood samples) drawn 4 hours after the completion of loading dose. Sequential trough levels drawn 30 minutes before each standard vancomycin dose for the next 4 doses. PK testing measures the amount of study drug in the body at different time points, with trough testing following 5 doses (1 dose every 8 to 12 hours).
Outcome Time Frame:
Up to 5 days
Safety Issue:
No
Principal Investigator
Ara Vaporciyan, MD, BS
Investigator Role:
Study Chair
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2009-0887
NCT ID:
NCT01157533
Start Date:
June 2010
Completion Date:
January 2012
Related Keywords:
- Infection
- Vancomycin
- Pharmacokinetic testing
- PK
- Critical Illness
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
