Evaluating voriconazole dosing in adult ECMO patients
An Observational Pharmacokinetic Study of Intravenous Voriconazole Used for Treatment of Invasive Aspergillosis in Adult Patients with Severe Influenza / COVID-19 Supported with Extra-corporeal Membrane Oxygenation (ECMO)
This study is testing how well voriconazole works in adults on ECMO to see if adjusting the dose can help treat invasive aspergillosis, especially in those also dealing with influenza or COVID-19.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals, Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT04868188 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pharmacokinetics of voriconazole in adults who are on extracorporeal membrane oxygenation (ECMO) support. It will involve taking blood samples to measure voriconazole plasma concentrations and a buccal swab to determine the CYP2C19 genotype. The study is designed to optimize voriconazole dosing to improve treatment outcomes for patients with invasive aspergillosis, particularly those co-infected with influenza or COVID-19. Participation will not alter treatment decisions, as voriconazole therapy will be initiated independently of the study protocol.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the ICU on ECMO support with confirmed influenza or COVID-19 and invasive aspergillosis.
Not a fit: Patients who are not on ECMO support or do not have a confirmed diagnosis of influenza or COVID-19 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dosing strategies for voriconazole, enhancing treatment efficacy and reducing toxicity in critically ill patients.
How similar studies have performed: While this approach is novel in the context of ECMO patients, previous studies have shown the importance of optimizing antifungal dosing in critically ill populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults aged ≥18 years 2. Admitted to ICU on ECMO support 3. Positive influenza or SARS-CoV-2 PCR from nasal, throat swab, BAL or other respiratory specimen. 4. 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: 1. No participants \< 18 years of age 2. Not requiring ECMO support 3. No positive influenza or SARS-CoV-2 results 4. 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.
Where this trial is running
Leicester
- University Hospitals of Leicester — Leicester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Hakeem Yusuff, MD — University Hospitals, Leicester
- Study coordinator: Hakeem Yusuff, MD
- Email: hakeem.yusuff@uhl-tr.nhs.uk
- Phone: 07789 880920
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.