- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03922451
Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
March 7, 2022 updated by: Katie Moynihan, Boston Children's Hospital
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric patients supported on ECMO
|
Administered for infection treatment or prophylaxis per hospital protocol
Administered for infection treatment or prophylaxis per hospital protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
|
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.
|
Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2019
Primary Completion (Actual)
April 1, 2020
Study Completion (Actual)
February 28, 2022
Study Registration Dates
First Submitted
April 15, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (Actual)
April 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 7, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-P00030970
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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