Critical IllnessEAT-PKNCT04674657
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
An observational study of Critical Illness and Extracorporeal Membrane Oxygenation Complication, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Critical Illness, Extracorporeal Membrane Oxygenation Complication, Infection
- What is being tested?
- blood drug concentration
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients on Extra-Corporeal Membrane Oxygenation
Who may be able to join
- Age >18 years and <90 years
- Currently undergoing ECMO for respiratory +/- cardiac dysfunction
- Clinical indication for the anti-infectives, including voriconazole, posaconazole and caspofungin
Who cannot join
- History of allergy to any of the study drug
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton & Harefield NHS Foundation Trust
Harefield, Middlesex, UB9 6JH
Haifa Lyster, 7850592073 ext. 7850592073, h.lyster@rbht.nhs.uk
About this study
Official title: Does Extra-Corporeal Membrane Oxygenation Alter Anti-infectives Therapy Pharmacokinetics in Adult Critically Ill Patients
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:
Read more
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.
Read the 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.
- Being tested
- blood drug concentration
- Medical subject headings
- Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drug concentrationDrug
blood drug concentration
| Study group | Role | What they receive |
|---|---|---|
| caspofungin | Adult critically ill patients on ECMO receiving caspofungin therapy Receives: Drug: blood drug concentration | |
| posaconazole | Adult critically ill patients on ECMO receiving posaconazole therapy Receives: Drug: blood drug concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start3 Sep 2018
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Reed, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674657
- Sponsor's protocol ID
- 18/LO/0691
- Acronym
- EAT-PK
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Extra-Corporeal Membrane Oxygenation Alter Anti-infectives Therapy Pharmacokinetics in Adult Critically Ill Patients
- ClinicalTrials.gov ID
- NCT04674657
- Acronym / sponsor ID
- EAT-PK / 18/LO/0691
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| caspofungin | – | Drug: blood drug concentrationAdult critically ill patients on ECMO receiving caspofungin therapy |
| posaconazole | – | Drug: blood drug concentrationAdult critically ill patients on ECMO receiving posaconazole therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients on Extra-Corporeal Membrane Oxygenation
Key inclusion criteria (3 listed)
- Age >18 years and <90 years
- Currently undergoing ECMO for respiratory +/- cardiac dysfunction
- Clinical indication for the anti-infectives, including voriconazole, posaconazole and caspofungin
Key exclusion criteria (2 listed)
- History of allergy to any of the study drug
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drug concentrationblood drug concentration | Drug | caspofungin, posaconazole |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Reed principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Extracorporeal Membrane Oxygenation Complication, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ms H Lyster (01895823737 ext. 85087, h.lyster@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration Versus Time Curve (AUC) of Caspofungin in adult critically ill patients on ECMO (time frame: 24 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.