Pharmacokinetics of Voriconazole in Adult ECMO Patients (NCT04868188) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetics of Voriconazole in Adult ECMO Patients
United Kingdom32 participantsStarted 2021-08-10
Plain-language summary
Given the high burden of fungal co-infection in patients admitted to ICU and improved outcomes with prompt anti-fungal treatment, it is of vital importance that the doses of anti-fungal are optimum to improve the dismal outcome of influenza/Covid-19 Associated Pulmonary Aspergillosis.
Due to the reported difficulties in dosing appropriately in ECMO patients, a prospective observational study is required to accurately evaluate the pharmacokinetics of voriconazole in patients supported on ECMO. This is to ensure that the dose of voriconazole is optimised to improve efficacy and reduce toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged ≥18 years
. Admitted to ICU on ECMO support
. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen.
. Positive invasive aspergillosis infection (positive Aspergillus species culture from respiratory specimen or positive serum galactomannan) or strong clinical suspicion of invasive aspergillosis infection based on symptoms, CT, CXR.
Exclusion criteria
. No participants \< 18 years of age
. Not requiring ECMO support
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied how voriconazole behaves in the blood of critically ill patients on ECMO — do the findings suggest that standard voriconazole dosing might need to be adjusted if I'm on ECMO support?
2Since this study is now completed, have the results been published, and if so, what did they show about whether ECMO affects voriconazole levels enough to matter for my treatment?
3Given that this trial focused on patients with suspected fungal infections like Aspergillosis alongside conditions like COVID-19 or influenza, does my specific situation match the kind of patients studied, and does that affect how relevant the findings are for me?
4Voriconazole blood levels can vary a lot from person to person — based on what this study found, would you consider doing therapeutic drug monitoring to check my voriconazole levels if I were prescribed it while on ECMO?
5Are there alternative antifungal treatments that have better-established dosing data for ECMO patients, and how would you weigh those options against voriconazole given what this research suggests?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma levels of voriconazole administered to critically ill adult patients with suspected fungal disease, receiving ECMO support.
Timeframe: 14 days
2
Plasma levels of voriconazole administered to critically ill adult patients with suspected fungal disease, receiving ECMO support.
Timeframe: 14 days
3
Plasma levels of voriconazole administered to critically ill adult patients with suspected fungal disease, receiving ECMO support.
Timeframe: 14 days
4
Plasma levels of voriconazole administered to critically ill adult patients with suspected fungal disease, receiving ECMO support.
Timeframe: 14 days
5
Plasma levels of voriconazole administered to critically ill adult patients with suspected fungal disease, receiving ECMO support.
. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.