Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Drug Effect Clinical Trial

Official title:

Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03922451
• Other study ID #: IRB-P00030970
• Status: Terminated
• Start date: August 27, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 28, 2022
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Effect

Intervention

Drug:
• piperacillin-tazobactam
Administered for infection treatment or prophylaxis per hospital protocol
• Cefazolin
Administered for infection treatment or prophylaxis per hospital protocol

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.
Primary	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.	Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.