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

NCT01157533 | Terminated Results

• 1 other identifier: 2009-0887
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Vancomycin; Pharmacokinetic testing; PK

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Vancomycin Loading

EXPERIMENTAL

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

Interventions

Vancomycin DRUG

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

Vancomycin Loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the Thoracic Surgery physician group
• Intravenous vancomycin therapy deemed necessary

You may not qualify if:

• Age less than 18 years
• History of hypersensitivity to vancomycin
• Patient weight greater than 150 kg
• 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.
• Prior exposure (within 7 days) to intravenous vancomycin
• 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.
• Current need for hemodialysis or continuous renal replacement therapy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

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

MeSH Terms

Conditions

Infections

Interventions

Vancomycin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Ara Vaporciyan, MD, BS/ Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Ara Vaporciyan, MD, BS

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2010
• First Posted: July 7, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 18, 2013
• Results First Posted: March 18, 2013

Record last verified: 2013-02

Locations

US (1)