N/A
N=13
Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)
Scedosporium Infection
Bottom Line
View on ClinicalTrials.gov: NCT01660334 ↗Enrolled (actual)
13
Serious AEs
16.7%
Results posted
Dec 2013
Primary outcome: Primary: Number of Participants With Serious Treatment Related Adverse Events. — 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Voriconazole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serious Treatment Related Adverse Events. |
2 | — |
| SECONDARY Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit. |
6 | — |
Summary
To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.
Eligibility Criteria
Inclusion Criteria
Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on Scedosporisis.
Exclusion Criteria
Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus, Candidasis,Cryptococcal infections not involving Scedosporisis.
Data sourced from ClinicalTrials.gov (NCT01660334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.