Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03922451
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Actual Duration (Months): 30.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Effect	Drug: piperacillin-tazobactam; Drug: Cefazolin

Study Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
• Actual Study Start Date: Aug 27, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Pediatric patients supported on ECMO	Drug: piperacillin-tazobactam; Administered for infection treatment or prophylaxis per hospital protocol; Drug: Cefazolin; Administered for infection treatment or prophylaxis per hospital protocol

Outcome Measures

Primary Outcome Measures

1. Plasma concentration: piperacillin-tazobactam [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.

2. Plasma concentration: cefazolin [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Children's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Katie Moynihan, Cardiac Intensivist, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT03922451
• Other Study ID Numbers: IRB-P00030970
• First Posted: Apr 22, 2019
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• 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
• Additional relevant MeSH terms: Cefazolin; Tazobactam; Piperacillin; Piperacillin, Tazobactam Drug Combination

Study Results

No Results Posted as of Mar 21, 2022