Surgical Site InfectionPhase 4NCT03453684

Pharmacokinetics of Preoperative Vancomycin

A Phase 4 study testing Administration of Vancomycin in people with Surgical Site Infection and Vancomycin, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A study of plasma and tissue vancomycin pharmacokinetics in pediatric surgical patients. Read more about this study

Who is it for?: Ages 31 days to 18 years
Conditions the study is for: Surgical Site Infection, Vancomycin
What is being tested?: Administration of Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2012to 20 Jul 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 31 days to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients

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

Read the detailed description

Background: Vancomycin is used for antibiotic prophylaxis in pediatric surgical patients without a complete understanding of plasma and soft tissue pharmacokinetics. Guidelines recommend incision within 60 minutes after administration; however, tissue concentrations of vancomycin at that early time may not be therapeutic. The Investigators conducted a study of plasma and tissue concentrations in pediatric neurosurgical and orthopedic patients to characterize intraoperative vancomycin pharmacokinetics.

Patients, ages (0.1-18.8 years), undergoing posterior spinal fusion (n=30) or ventriculoperitoneal shunt placement (n=30), received intravenous vancomycin 15 mg/kg over one hour. Skin biopsies were taken at incision and skin closure. Blood samples were also collected at incision and closure; additional samples were drawn at 2- and 4-hours if patient was still in surgery. Population pharmacokinetic (PK) analysis was performed to characterize PK parameter estimates and to develop a model of intraoperative plasma and tissue vancomycin concentrations vs. time.

Conditions: Surgical Site Infection, Vancomycin
Being tested: Administration of Vancomycin
Medical subject headings: Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Administration of VancomycinDrug
Also called Vancomycin Hydrochloride
Intravenous Vancomycin Administration

Study groups in NCT03453684
Study group	Role	What they receive
Administration of Vancomycin	Experimental	Administration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision Receives: Drug: Administration of Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201220 Jul 2015

First posted5 Mar 2018
Study start1 Dec 2012
Primary completionJun 2013
Study completion20 Jul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03453684
Sponsor's protocol ID: 12-1411
Status last verified: Apr 2022
First submitted: 14 Feb 2018
Last updated: 24 May 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Site Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preoperative Vancomycin Administration for Surgical Site Prophylaxis: Plasma and Soft Tissue Concentrations in Pediatric Neurosurgical and Orthopedic Patients
ClinicalTrials.gov ID: NCT03453684
Acronym / sponsor ID: 12-1411
Conditions: Surgical Site Infection, Vancomycin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Study start: 1 Dec 2012 (actual)
Primary completion: Jun 2013 (actual)
Study completion: 20 Jul 2015 (actual)
First posted: 5 Mar 2018 (actual)
Results: Posted 24 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Administration of Vancomycin	Experimental	Drug: Administration of VancomycinAdministration of Vancomycin 15 mg/kg over 1 hour prior to surgical incision

Who may qualify

Ages: 31 days to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Administration of VancomycinAlso: Vancomycin HydrochlorideIntravenous Vancomycin Administration	Drug	Administration of Vancomycin

Primary outcome

Pharmacokinetics Analysis: V˅c
Time frame: 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).
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.
Pharmacokinetics Analysis: V˅2
Time frame: 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).
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.
Pharmacokinetics Analysis: Q
Time frame: 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).
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.
Pharmacokinetics Analysis: Cle
Time frame: 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).
Elimination clearance. This outcome measure was pre-specified to utilize advanced mathematical modeling for this assessment. No measure of central tendency is available.
Pharmacokinetics Analysis: sf˅V2
Time frame: 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).
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.
Pharmacokinetics Analysis: sf˅Cle
Time frame: 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).
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.
Pharmacokinetics Analysis: K˅skin0
Time frame: 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)
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.
Pharmacokinetics Analysis: PC
Time frame: 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)
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.
Pharmacokinetics Analysis: δ ˅R-plasma
Time frame: 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)
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.
Pharmacokinetics Analysis: δ ˅A-skin
Time frame: 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)
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.

Results and safety

Results posted to the registry on 24 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Administration of Vancomycin	60	60

Primary outcome: Pharmacokinetics Analysis: V˅c

Time frame: 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).. Number. Unit: L

Measure	Administration of Vancomycin n = 59
Typical value	2.56
w^2	1.14

Administration of Vancomycin: Overall SE of the estimate: 0.009

Population analysed: One participant was excluded because the sample was lost.

Primary outcome: Pharmacokinetics Analysis: V˅2

Time frame: 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).. Number. Unit: L/35kg

Measure	Administration of Vancomycin n = 59
Value	5.30

Administration of Vancomycin: Overall Standard Error of the Estimate: 9.85

Population analysed: One participant was excluded because the sample was lost.

Primary outcome: Pharmacokinetics Analysis: Q

Time frame: 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).. Number. Unit: L/min

Measure	Administration of Vancomycin n = 59
Value	0.12

Administration of Vancomycin: Overall Standard Error of the Estimate: 8.37

Population analysed: One participant was excluded because the sample was lost.

Primary outcome: Pharmacokinetics Analysis: Cle

Time frame: 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).. Number. Unit: L/min/1.73 m^2

Measure	Administration of Vancomycin n = 59
Typical value	0.09
ꙍ^2 (Intersubject variability)	0.13

Administration of Vancomycin: Overall Standard Error of the Estimate: 4.83

Population analysed: One participant was excluded because the sample was lost.

Adverse events

Time frame: 1 day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Administration of Vancomycin	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Melissa Brooks-Peterson, MD principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Administration of Vancomycin in people with Surgical Site Infection and Vancomycin, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Analysis: V˅c (time frame: 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).). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03453684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.