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

This study has been terminated.
(Low Accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01157533
First received: July 5, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Infection
Drug: Vancomycin

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Percent of Participants Attaining Target Trough of 15-20 mg/L Following 30 mg/kg Loading Dose [ Time Frame: Up to 5 days ] [ Designated as safety issue: No ]
    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).


Enrollment: 1
Study Start Date: June 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157533

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Ara Vaporciyan, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01157533     History of Changes
Other Study ID Numbers: 2009-0887
Study First Received: July 5, 2010
Results First Received: February 13, 2013
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Vancomycin
Pharmacokinetic testing
PK

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014