Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancomycin Loading

Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

Group Type EXPERIMENTAL

Vancomycin

Intervention Type DRUG

Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

Interventions

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Vancomycin

Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

Intervention Type DRUG

Eligibility Criteria

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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) \</= 30 mL/min by Cockcroft-Gault equation.
7. Current need for hemodialysis or continuous renal replacement therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No