Pharmacokinetics of Preoperative Vancomycin

NCT03453684 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 12-1411
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients.

Conditions

Surgical Site Infection; Vancomycin

Outcome Measures

Primary Outcomes (10)

• Pharmacokinetics Analysis: V˅c

  Volume of the central compartment. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: V˅2

  Volume of the peripheral compartment Typical value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: Q

  Intercompartmental clearance between central compartment (Vc) and peripheral compartment (V2) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: Cle

  Elimination clearance. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: sf˅V2

  Scaling Factor for Body weight covariate for V2 (Volume of the peripheral compartment) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: sf˅Cle

  Scaling Factor for Body weight covariate for Cle (elimination clearance) Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed).

• Pharmacokinetics Analysis: K˅skin0

  Accounts for the equilibration rate between plasma and skin. Typical Value should be read as 3.6E-05. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)

• Pharmacokinetics Analysis: PC

  Partition coefficient, models skin drug concentration between plasma and skin. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)

• Pharmacokinetics Analysis: δ ˅R-plasma

  Proportional or relative intrasubject variability for plasma data Typical Value. There is no unit of measure for this measurement. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)

• Pharmacokinetics Analysis: δ ˅A-skin

  Additive intrasubject variability for skin data Typical Value. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.

  1 Day (measured and combined from the time of the incision, through 2 hours after the incision, 4 hours after the incision, until when the incision is closed)

Study Arms (1)

Administration of Vancomycin

EXPERIMENTAL

Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision

Drug: Administration of Vancomycin

Interventions

Administration of Vancomycin DRUG

Intravenous Vancomycin Administration

Also known as: Vancomycin Hydrochloride

Administration of Vancomycin

Eligibility Criteria

• Age: 31 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Neurosurgery patients between the ages of 31 days up to 18 years
• Receiving a single dose of vancomycin administered prior to surgery for cerebrospinal fluid (CSF) shunt placement or revision.
• Orthopedic surgical patients between the ages of 31 days up to 18 years
• Receiving a single dose of vancomycin administered prior to surgery for definitive spinal fusion.

You may not qualify if:

• Patients already receiving vancomycin for treatment of an active infection,
• Patients who have a Creatinine ≥1.2,
• Patients who's creatinine clearance less than 50,
• Known chronic renal failure and are on dialysis,
• Patients with a known allergy to vancomycin, not including Red Man Syndrome.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Outcome measures were determined by complex mathematical modeling utilizing the pharmacokinetics estimates listed above. Outcome measures are described as necessary report the pharmacokinetic data. Outcome measures reflect the study protocol.

Results Point of Contact

• Title: Melissa Brooks-Peterson, MD
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

30372411111

Study Officials

• Melissa Brooks-Peterson, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 5, 2018
• Study Start: December 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 20, 2015
• Last Updated: May 24, 2022
• Results First Posted: May 24, 2022

Record last verified: 2022-04

Locations

US (1)