Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)

Completed

• Conditions: Scedosporium Infection
• Interventions: Drug: Voriconazole

• Registration Number: NCT01660334
• Lead Sponsor: Pfizer

Brief Summary

To collect the efficacy and safety information of voriconazole related to their appropriate use in daily practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-08
• Results First Submitted: 2013-05-14
• Status Verified: 2013-10
• Results First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Results First Posted: 2013-12-17
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Voriconazole	Voriconazole	Subjects who are treated with voriconazole

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serious Treatment Related Adverse Events.	16 weeks	Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.	16 weeks	The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.; Clinical response of cure was assessed comprehensively by physicians in the three categories, which were "effective", "ineffective", and "not evaluable", based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.