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

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.

Study Overview

• Status: Terminated
• Conditions: Infection
• Intervention / Treatment: Drug: Vancomycin

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Vancomycin; Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Study Chair: Ara Vaporciyan, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

Helpful Links

• The University of Texas (UT) MD Anderson Cancer Center website

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: July 5, 2010
• First Submitted That Met QC Criteria: July 5, 2010
• First Posted (ESTIMATE): July 7, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Vancomycin; PK; Pharmacokinetic testing
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 2009-0887