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.
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
Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose
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).
Up to 5 days
Ara Vaporciyan, MD, BS
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|