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

NCT04674657 | Unknown

• 1 other identifier: 18/LO/0691
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Extracorporeal Membrane Oxygenation Complication; Infection

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration Versus Time Curve (AUC) of Caspofungin in adult critically ill patients on ECMO

  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

  24 hour

• Area Under the Plasma Concentration Versus Time Curve (AUC) of Posaconazole in adult critically ill patients on ECMO

  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

  24 hour

Study Arms (2)

caspofungin

Adult critically ill patients on ECMO receiving caspofungin therapy

Drug: blood drug concentration

posaconazole

Adult critically ill patients on ECMO receiving posaconazole therapy

Drug: blood drug concentration

Interventions

blood drug concentration DRUG

blood drug concentration

caspofungin; posaconazole

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critically ill patients on Extra-Corporeal Membrane Oxygenation

You may qualify if:

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

You may not qualify if:

• History of allergy to any of the study drug
• Pregnant women

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Royal Brompton & Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna Reed

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ms H Lyster

CONTACT

01895823737; h.lyster@rbht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: September 3, 2018
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

GB (1)