CClinicalTrials.gg
Status unknownNCT01661361Updated Aug 9, 2012

Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

An observational study in Catheter-related Infection, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study summary

Recently, it was reported that when vancomycin levels are determined after port sampling, levels can be falsely increased potentially leading to wrong dose adjustments.

The investigators conducted an in vitro experiment using several central venous port devices, in which different flushing techniques were evaluated yielding residual vancomycin levels of less than 0.5 mg/L.

In this study, the investigators want to evaluate this flushing technique in vivo in 15 patients admitted with catheter-related infection and treated with systemic vancomycin and vancomycin antibiotic lock.

The purpose is to assess if correct flushing can avoid spurious vancomycin levels obtained via port sampling.

02

Conditions studied

  • Catheter-related Infection

Keywords

  • vancomycin
  • levels
  • central venous port device
  • peripherally obtained levels
  • dose adjustments
  • TDM
03

In context

Catheter-Related Infections

107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.

This study's planned enrollment of 15 is below the median of 200 across 25 observational studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients admitted for catheter related infection with methicillin-resistant coagulase-negative staphylococci (MR-CNS) and treated with systemic vancomycin in combination with vancomycin antibiotic lock via central venous port device.

Inclusion criteria

  • adult patients,
  • having central venous port device,
  • treated with systemic vancomycin in combination with vancomycin antibiotic lock

Exclusion criteria

Exclusion Criteria:

  • pregnant women,
  • children,
  • patients with 'do not resuscitate' (DNR) code
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • vancomycin cohort

    Procedure: blood levels

Interventions

  • Procedureblood levels
06

What researchers measure

Primary outcomes

  1. comparison of central (via port device) and peripherally obtained vancomycin levels: the difference, when using the new flushing technique, is allowed to be maximally 0.5 mg/L

    Time frame: central and peripheral vancomycin levels will be obtained during steady state: this means starting from the 4th dose (= day 2) of vancomycin treatment. Vancomycin is usually given during 14 days after the last positive blood culture.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01661361
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Isabelle Spriet (PharmD, PhD, Universitaire Ziekenhuizen KU Leuven) — Principal investigator
First posted
Aug 9, 2012
Start date
Sep 2012
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Aug 9, 2012

Study contacts

Isabel Spriet, PharmD PhD
Contact
isabel.spriet@uzleuven.be
0032 16 34 30 80
Jan Verhaegen, MD PhD
Contact
jan.verhaegen@uzleuven.be
0032 16 33 22 11
Isabel Spriet, PharmD PhD
principal investigator · Pharmacy Dpt, University Hospitals Leuven
Jan Verhaegen, MD PhD
study chair · Medical Diagnostic Sciences, University Hospitals Leuven
Hans Prenen, MD PhD
study chair · Digestive ONcology, University Hosptials Leuven
Willy Peetermans, MD PhD
study chair · Internal Medicine, University Hospitals Leuven
Ludo Willems, PharmD PhD
study chair · Pharmacy Dpt., University Hosptials Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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