Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 5:26 AM
Study NCT ID:
NCT01157533
Status:
TERMINATED
Last Update Posted:
2013-03-18
First Post:
2010-07-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if giving a larger than normal "loading dose" of the antibiotic vancomycin before starting standard vancomycin dosing can help patients reach and maintain the needed blood-level of the antibiotic during treatment.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: