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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Hakeem
Yusuff
hakeem.yusuff@uhl-tr.nhs.uk
Dr
Hussain
Mulla
hussain.mulla@uhl-tr.nhs.uk
MycosesProvisional assignment of new diseases of uncertain etiologyInfluenza and pneumonia
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Extracorporeal membrane oxygenation (ECMO) is a life support system for the heart and lungs of critically ill patients. The ECMO machine is similar to the heart-lung by-pass machine used in open-heart surgery. It pumps and oxygenates a patient's blood outside the body, allowing the heart and lungs to rest.
Voriconazole is an antifungal drug and has shown to be highly effective at treating fungal infections at recommended doses in normal ICU patients. However, dosing information in patients requiring ECMO support is lacking. This may be important as it is known that ECMO circuits alter how drugs are handled by the body. The purpose of this study is to determine whether we are getting the dose of voriconazole right for adult patients on ECMO support.
This is a pharmacokinetic study of intravenous voriconazole administered to adults (> 18 years) receiving ECMO support in the ICU at Glenfield Hospital, Leicester. Based on historical data, an estimated 30 patients are expected to be recruited over the study period.
Patients recruited to the study will receive intravenous voriconazole as part of their clinical management plan. The decision to administer or commence on IV voriconazole will be based solely on clinical assessment of the patient by the responsible clinical team and will not be influenced in any way by the research or members of the research team. The study does not require randomisation or blinding.
Patients will be administered twice daily doses of voriconazole for the duration of therapy, typically for a maximum of 14-28 days (the typical duration of anti-fungal treatment on ECMO). The duration of study for each patient will be therefore up to 28 days and the study will last for 18 months.
Currently in routine clinical care, voriconazole is monitored during treatment by taking a single blood sample to check the concentration. This is usually done on one occasion after at least 3-4 doses have been administered. In this study, 5 blood samples will be taken across 3 dosing occasions to determine concentrations of voriconazole and to build a pharmacokinetic model. In addition, a genetic test for the enzyme CYP2C19 will be done by taking a cheek swab. This enzyme is responsible for breaking down voriconazole in the body. The genetic test will determine if different genotypes of this enzyme affects the concentration of voriconazole in blood.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
1. No participants < 18 years of age 2. Not requiring ECMO support 3. No positive influenza or SARS-Cov-2 results. 4. Females who are pregnant. 5. Hypersensitivity to voriconazole or any of the excipients in the formulation. 6. Concurrently administered the following CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine since increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes. 7. Concurrently administered rifampicin, carbamazepine or phenobarbital since these medicinal products are likely to decrease plasma voriconazole concentrations significantly. 8. Concurrently administered efavirenz doses of 400 mg once daily or higher because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. Voriconazole also significantly increases efavirenz plasma concentrations. 9. Concurrently administered high-dose ritonavir (400 mg and above twice daily) because ritonavir significantly decreases plasma voriconazole concentrations in healthy subjects at this dose. 10. Concurrently administered ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates, since increased plasma concentrations of these medicinal products can lead to ergotism. 11. Concurrently administered sirolimus since voriconazole is likely to increase plasma concentrations of sirolimus significantly. 12. Concurrently administered St. John's Wort. 13. 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.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST and funded by NIHR Central Commissioning Facility (CCF) .
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for Trial ID: CPMS 48619
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