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Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients

NCT04674657 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-12-19

No results posted yet for this study

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.

Conditions

  • Critical Illness
  • Extracorporeal Membrane Oxygenation Complication
  • Infection

Interventions

DRUG

blood drug concentration

blood drug concentration

Sponsors & Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Anna Reed · Royal Brompton and Harefield NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674657 on ClinicalTrials.gov