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Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients (EAT-PK)

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ClinicalTrials.gov Identifier: NCT04674657
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Study Description
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Brief Summary:

Observational study Primary Objective: To study whether ECMO alters the PK of anti-infectives including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Secondary Objectives:

Develop Population PK models of anti-infectives, including voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Develop Physiological-Based PK (PBPK) model of anti-infectives, including: voriconazole, posaconazole and caspofungin in critically ill patients on ECMO

Study population: Critically ill patients on ECMO

Methodology: Observational study to determine whether ECMO alters the PK of anti-infectives, by developing PK models

This is a non-interventional descriptive study in that the anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols in line with patient's routine care. Patients will be asked to provide additional blood samples over the course of the anti-infective dosing schedule, these samples will be taken from existing arterial lines to help guide treatment in future patients on ECMO receiving these anti-infectives.


Condition or disease Intervention/treatment
Critical Illness Extracorporeal Membrane Oxygenation Complication Infection Drug: blood drug concentration

Detailed Description:

Anti-infective drug selection and dosing will be at the discretion of the clinician, based on the clinical context and unit guidelines. Doses will be reconstituted and administered as per local hospital protocols and based on routine standard care.

Blood samples will be drawn from an existing arterial line and collected in 3 ml tubes with Lithium Heparin anticoagulant.

All patients will be sampled over a single dosing period on the second day of Extra-Corporeal Membrane Oxygenation (ECMO) treatment, or of an antibiotic course where antibiotics are commenced whilst the patient is on ECMO. Where possible, sampling during one extra dosing interval will occur on days 4-8 of ECMO treatment and/or prior to the next tubing change. Where two or more anti-infectives of interest are prescribed for one patient, collect data on timing of administration for both drugs and sample according to the antibiotic with the longer dosing interval.

Blood samples (2ml) will be collected from an existing arterial line at the following time points 0 (pre-starting infusion, pre-Nasogastric (NG)/Oral (PO) dose), 1 (end of infusion or 1hour post NG/PO dose), 2, 3, 4, 8 and either 12 (for twice daily regimen) or 24 (for once daily regimen) hours on the second day of ECMO.

Where a patient is receiving medications where a validated drug assay exists in addition to the study drug (such as other anti-infectives), analysis of the additional therapy will also be attempted where practical.

Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Does Extra-Corporeal Membrane Oxygenation Alter Anti-infectives Therapy Pharmacokinetics in Adult Critically Ill Patients
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
caspofungin
Adult critically ill patients on ECMO receiving caspofungin therapy
 Drug: blood drug concentration
blood drug concentration
posaconazole
Adult critically ill patients on ECMO receiving posaconazole therapy
 Drug: blood drug concentration
blood drug concentration


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration Versus Time Curve (AUC) of Caspofungin in adult critically ill patients on ECMO [ Time Frame: 24 hour ]
    Blood samples (2ml) will be collected from an existing arterial line at the following time points 0 (pre-starting infusion, pre-NG/PO dose), 1 (end of infusion or 1hour post NG/PO dose), 2, 3, 4, 8 and either 12 (for twice daily regimen) or 24 (for once daily regimen) hours on the second day of ECMO

  2. Area Under the Plasma Concentration Versus Time Curve (AUC) of Posaconazole in adult critically ill patients on ECMO [ Time Frame: 24 hour ]
    Blood samples (2ml) will be collected from an existing arterial line at the following time points 0 (pre-starting infusion, pre-NG/PO dose), 1 (end of infusion or 1hour post NG/PO dose), 2, 3, 4, 8 and either 12 (for twice daily regimen) or 24 (for once daily regimen) hours on the second day of ECMO


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients on Extra-Corporeal Membrane Oxygenation
Criteria

Inclusion Criteria:

  1. Age >18 years and <90 years
  2. Currently undergoing ECMO for respiratory +/- cardiac dysfunction
  3. Clinical indication for the anti-infectives, including voriconazole, posaconazole and caspofungin

Exclusion Criteria:

  1. History of allergy to any of the study drug
  2. Pregnant women
Contacts and Locations
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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): NCT04674657


Contacts
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Contact: Ms H Lyster 01895823737 ext 85087 h.lyster@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton & Harefield NHS Foundation Trust Recruiting
Harefield, Middlesex, United Kingdom, UB9 6JH
Contact: Haifa Lyster    7850592073 ext 7850592073    h.lyster@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Anna Reed Royal Brompton and Harefield NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Royal Brompton & Harefield NHS Foundation Trust:
Study Protocol and Statistical Analysis Plan  [PDF] March 23, 2018

More Information
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04674657    
Other Study ID Numbers: 18/LO/0691
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
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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Critical Illness
Disease Attributes
Pathologic Processes