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Clinical Trials/NCT03922451
NCT03922451
Terminated
Not Applicable

Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Boston Children's Hospital1 site in 1 country4 target enrollmentAugust 27, 2019

Overview

Phase
Not Applicable
Intervention
piperacillin-tazobactam
Conditions
Drug Effect
Sponsor
Boston Children's Hospital
Enrollment
4
Locations
1
Primary Endpoint
Plasma concentration: cefazolin
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo setting.

Registry
clinicaltrials.gov
Start Date
August 27, 2019
End Date
February 28, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katie Moynihan

Cardiac Intensivist

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • supported on ECMO
  • receive piperacillin-tazobactam or cefazolin as part of routine care or infection management

Exclusion Criteria

  • \>= 18 years
  • No Consent provided

Arms & Interventions

Pediatric patients supported on ECMO

Intervention: piperacillin-tazobactam

Pediatric patients supported on ECMO

Intervention: Cefazolin

Outcomes

Primary Outcomes

Plasma concentration: cefazolin

Time Frame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.

Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.

Plasma concentration: piperacillin-tazobactam

Time Frame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.

Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.

Study Sites (1)

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