EUCTR2017-000197-11-Outside-EU/EEA
Active, not recruiting
Phase 1
Post Marketing Surveillance Study To Evaluate The Safety And Efficacy Of Vfend® IV
DrugsVfend®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pfizer Inc.
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed as ‘invasive aspergillosis’, ‘serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of, or refractory to, other therapy’ or ‘candidemia in nonneutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds’ who have received Vfend IV will be included in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 250
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 100
Exclusion Criteria
- •Vfend® is contraindicated in the following patients:
- •\-Patients with known hypersensitivity to voriconazole or to any of the excipients.
- •\-Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine with voriconazole : Increased plasma concentrations of these medicinal products can lead to QTc prolongation and rare occurrences of torsades de pointes.
- •\-Coadministration of voriconazole with rifampicin, carbamazepine and Phenobarbital: These medicinal products are likely to decrease plasma voriconazole concentrations significantly.
- •\-Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates : Increased plasma concentrations of these medicinal products can lead to ergotism.
- •\-Coadministration of voriconazole and sirolimus: Voriconazole is likely to increase plasma concentrations of sirolimus significantly.
- •\-Coadministration of voriconazole with high\-dose ritonavir (400 mg and above twice daily) is contraindicated because ritonavir significantly decreased plasma voriconazole concentrations in healthy subjects at this dose.
- •\-Coadministration of voriconazole with efavirenz : Efavirenz significantly decreased voriconazole plasma concentrations while voriconazole also significantly increased efavirenz plasma concentrations.
- •\-Coadministration of voriconazole with St John’s Wort is contraindicated.
Outcomes
Primary Outcomes
Not specified
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