A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
Primary Purpose
Candidiasis, Cryptococcosis, Aspergillosis
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at 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.
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.
Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.
Secondary Outcome Measures
Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.
Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
Change from baseline in electrocardiogram at Week 1 and end of therapy.
Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00647907
Brief Title
A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
Official Title
An Open Label, Non-comparative, Multicenter Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infection
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Cryptococcosis, Aspergillosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Intervention Description
Oral or intravenous voriconazole. Oral tablets 400 mg twice daily loading dose on first day, followed by 200 mg twice daily taken at least 1 hour before or after a meal. Oral doses could be increased to a maximum of 300 mg twice daily if there was no clinical improvement after at least 3 days of treatment, no serious adverse events were reported, and clinical chemistry parameters were within the acceptable range for study entry. Intravenous treatment was initiated with a loading dose of 6 mg/kg twice daily for the first day followed by 4 mg/kg twice daily for at least 3 days (maximum infusion rate of 3 mg/kg/hr if administered by peripheral intravenous line). An intravenous loading dose was not required in patients who were restarted after oral treatment. Total duration of therapy (intravenous and oral) was 12 weeks.
Primary Outcome Measure Information:
Title
Serological response (evaluated by approved diagnostic serological tests [cryptococcosis, coccidiomycosis, and histoplasmosis]) at Weeks 2, 8, 12, and end of therapy.
Time Frame
Weeks 2, 8, 12, and end of therapy
Title
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.
Time Frame
Weeks 1, 2, 4, 8, 12 and end of therapy
Title
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.
Time Frame
Weeks 2, 8, 12, and end of therapy
Title
Mycological response (evaluated by the presences of fungal pathogen by relevant specimen [microscopy or histopathology]) at Weeks 2, 8, 12, and end of therapy.
Time Frame
Weeks 2, 8, 12, and end of therapy
Secondary Outcome Measure Information:
Title
Global response to treatment (incorporating clinical, mycological, radiological, and serological responses as applicable) at end of therapy/Week 16.
Time Frame
End of therapy or Week 16
Title
Change from baseline in laboratory parameters at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
Time Frame
Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up
Title
Change from baseline in electrocardiogram at Week 1 and end of therapy.
Time Frame
Week 1 and end of therapy
Title
Incidence of adverse events at Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up.
Time Frame
Weeks 1, 2, 4, 8, 12, end of therapy, Week 16, and follow-up
Title
Visual safety testing at Weeks 1, 8, 12, end of therapy, Week 16, and follow-up.
Time Frame
Weeks 1, 8, 12, end of therapy, Week 16, and follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Kaohsiung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501018&StudyName=A%20Study%20of%20the%20Efficacy%20and%20Safety%20of%20Voriconazole%20for%20the%20Treatment%20of%20Fungal%20Infections
Description
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A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
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