An observational study in Drug Effect, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-21.
Sponsored by Boston Children's Hospital · Observational
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.
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 149 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 19 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
All pediatric patients who are supported on ECMO at Boston Children's Hospital Cardiac Intensive Care Unit (CICU) and receive piperacillin-tazobactam or cefazolin as part of routine care or infection management.
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Exclusion Criteria:
Drug: piperacillin-tazobactam · Drug: Cefazolin
Administered for infection treatment or prophylaxis per hospital protocol
Administered for infection treatment or prophylaxis per hospital protocol
Plasma concentration: piperacillin-tazobactam
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.
Time frame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Plasma concentration: cefazolin
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.
Time frame: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Ran from Aug 2019 to primary completion in Apr 2020, 7 months.
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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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