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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Isabelle Spriet, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01661361
First received: July 20, 2012
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Catheter-related Infection
Procedure: blood levels

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimalisation of Therapeutic Drug Monitoring (TDM) of Vancomycin in Patients With Central Venous Port Devices

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples


Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
vancomycin cohort Procedure: blood levels

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant women,
  • children,
  • patients with 'do not resuscitate' (DNR) code
  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: NCT01661361

Contacts
Contact: Isabel Spriet, PharmD PhD 0032 16 34 30 80 isabel.spriet@uzleuven.be
Contact: Jan Verhaegen, MD PhD 0032 16 33 22 11 jan.verhaegen@uzleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Isabel Spriet, PharmD PhD Pharmacy Dpt, University Hospitals Leuven
Study Chair: Jan Verhaegen, MD PhD Medical Diagnostic Sciences, University Hospitals Leuven
Study Chair: Hans Prenen, MD PhD Digestive ONcology, University Hosptials Leuven
Study Chair: Willy Peetermans, MD PhD Internal Medicine, University Hospitals Leuven
Study Chair: Ludo Willems, PharmD PhD Pharmacy Dpt., University Hosptials Leuven
  More Information

No publications provided

Responsible Party: Isabelle Spriet, PharmD, PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01661361     History of Changes
Other Study ID Numbers: S54585
Study First Received: July 20, 2012
Last Updated: August 8, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
vancomycin
levels
central venous port device
peripherally obtained levels
dose adjustments
TDM

Additional relevant MeSH terms:
Catheter-Related Infections
Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014