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)

Status: Recruiting
Location: See location...
Intervention Type: Other, Genetic
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
University Hospitals of Leicester
RECRUITING
Leicester
Contact Information
Primary
Hakeem Yusuff, MD
hakeem.yusuff@uhl-tr.nhs.uk
07789 880920
Backup
Hussain Mulla, PhD
hussain.mulla@uhl-tr.nhs.uk
07702 559537
Time Frame
Start Date: 2021-08-24
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 50
Treatments
Voriconazole administration to adult patients with suspected fungal disease, receiving ECMO support
Adult (\>18 years) patients with severe influenza / Covid-19 supported on ECMO and with confirmed or suspected aspergillosis infection.
Related Therapeutic Areas
Sponsors
Leads: University Hospitals, Leicester

This content was sourced from clinicaltrials.gov