NCT01661361|Unknown
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Sponsor study identifier
observational
15
0 countries
N/A
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 20, 2012
Actual (reported)August 9, 2012
Actual (reported)September 2012
Date type not reportedThis date has not been verified as actual or estimated.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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.
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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.
blood samples
Isabel Spriet, PharmD PhD
Pharmacy Dpt, University Hospitals Leuven
Jan Verhaegen, MD PhD
Medical Diagnostic Sciences, University Hospitals Leuven
Hans Prenen, MD PhD
Digestive ONcology, University Hosptials Leuven
Willy Peetermans, MD PhD
Internal Medicine, University Hospitals Leuven
First Submitted
July 20, 2012
First Posted
August 9, 2012
Study Start
September 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Estimated (date passed)Contact the study team to confirm eligibility.
Ludo Willems, PharmD PhD
Pharmacy Dpt., University Hosptials Leuven
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 9, 2012
Record last verified: 2012-08
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Source: ClinicalTrials.gov.
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