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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01157533
• Other study ID #: 2009-0887
• Status: Terminated
• Phase: N/A
• First received: July 5, 2010
• Last updated: February 13, 2013
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Infection

Intervention

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.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

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