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Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support

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ClinicalTrials.gov Identifier: NCT03922451
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Katie Moynihan, Boston Children’s Hospital

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
Drug Effect Drug: piperacillin-tazobactam Drug: Cefazolin

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacokinetics of Antibiotics During Extracorporeal Membrane Oxygenation (ECMO) Support
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort 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




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922451


Contacts
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Contact: Katie M Moynihan, MBBS 6177126121 katie.moynihan@cardio.chboston.org
Contact: Viviane Nasr, MD 6173556225 Viviane.Nasr@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Katie Moynihan, Cardiac Intensivist, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03922451     History of Changes
Other Study ID Numbers: IRB-P00030970
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019

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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:
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Anti-Bacterial Agents
Cefazolin
Tazobactam
Piperacillin
Piperacillin, Tazobactam Drug Combination
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action