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

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

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

Study Overview

• Status: Completed
• Conditions: Candidiasis; Aspergillosis; Cryptococcosis
• Intervention / Treatment: Drug: Voriconazole

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Pfizer Investigational Site
  • Taichung, Taiwan, 40705
    • Pfizer Investigational Site
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
  • Taipei, Taiwan, 114
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A

Drug: Voriconazole; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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
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
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

Outcome Measure	Time Frame
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
Change from baseline in electrocardiogram at Week 1 and end of therapy.	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.	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.	Weeks 1, 8, 12, end of therapy, Week 16, and follow-up

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Study Completion (Actual): May 1, 2004

Study Registration Dates

• First Submitted: March 27, 2008
• First Submitted That Met QC Criteria: March 27, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): May 16, 2011
• Last Update Submitted That Met QC Criteria: May 12, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Candidiasis; Mycoses; Aspergillosis; Cryptococcosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Voriconazole
• Other Study ID Numbers: A1501018