A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections

Phase 4

Completed

• Conditions: Candidiasis; Cryptococcosis; Aspergillosis
• Interventions: Drug: Voriconazole

• Registration Number: NCT00647907
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2004-05
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-03-27
• Study First Posted: 2008-04-01
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Systemic or invasive fungal infection
• Infection caused by organism for which there is no current treatment or infection with evidence of failure and/or intolerance to treatment with approved antifungal agents

Exclusion Criteria

• Liver function test abnormalities
• Renal disease
• Fungal infections not considered to be invasive or systemic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Voriconazole	-

Primary Outcome Measures

Name	Time	Method
Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.	Weeks 2, 8, 12, and end of therapy
Radiological response (evaluated based on all radiological abnormalities [X-ray, computed tomography scan] attributed to fungal infection compared to baseline) at Weeks 2, 8, 12, and end of therapy.	Weeks 2, 8, 12, and end of therapy
Clinical response (evaluated based on change of attributable symptoms, signs, and/or bronchoscopic abnormalities present at baseline, judged by investigators, at Weeks 1, 2, 4, 8, 12, and end of therapy) at Weeks 1, 2, 4, 8, 12, and end of therapy.	Weeks 1, 2, 4, 8, 12 and end of therapy
Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.	Weeks 2, 8, 12, and end of therapy

Secondary Outcome Measures

Name	Time	Method
Change from baseline in electrocardiogram at Week 1 and end of therapy.	Week 1 and end of therapy
Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.	Weeks 1, 8, 12, end of therapy, Week 16, and follow-up
Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.	End of therapy or Week 16
Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.	Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up
Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.	Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Taipei, Taiwan