Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

Catheter Related Blood Stream Infections Clinical Trial

Official title:

Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03720132
• Other study ID #: S20140519
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 30, 2018

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

Description:

In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously.

Flushing will be done with sodium chloride 0.9 % solution.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 30, 2018
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Pediatric patients with a port catheter

• Treated with systemic vancomycin and/or vancomycin "lock"

Exclusion Criteria:

• Age > 18 years

• Active downgrading of care

Related Conditions & MeSH terms

• Catheter Related Blood Stream Infections

Intervention

Procedure:
• Extensive flushing of the port catheter
The port catheter will be flushed extensively with sodium chloride 0.9% before blood sampling. Blood sampling will occur through the central catheter and peripherally simultaneously.

Locations

Country	Name	City	State
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum in: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457. — View Citation

Rybak MJ, Lomaestro BM, Rotschafer JC, Moellering RC, Craig WA, Billeter M, Dalovisio JR, Levine DP. Vancomycin therapeutic guidelines: a summary of consensus recommendations from the infectious diseases Society of America, the American Society of Health-System Pharmacists, and the Society of Infectious Diseases Pharmacists. Clin Infect Dis. 2009 Aug 1;49(3):325-7. doi: 10.1086/600877. Erratum in: Clin Infect Dis. 2009 Nov 1;49(9):1465. — View Citation

Wright DF, Al-Sallami HS, Jackson PM, Reith DM. Falsely elevated vancomycin plasma concentrations sampled from central venous implantable catheters (portacaths). Br J Clin Pharmacol. 2010 Nov;70(5):769-72. doi: 10.1111/j.1365-2125.2010.03749.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vancomycin trough levels via port catheter and peripheral vein	Vancomycin trough levels will be determined, both on peripheral blood and blood taken via the port catheter and will be compared.	At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose