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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00647907
First Posted: April 1, 2008
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections

Condition Intervention Phase
Candidiasis Cryptococcosis Aspergillosis Drug: Voriconazole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 Measures:
  • 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 ]
  • 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 ]
  • Change from baseline in electrocardiogram at Week 1 and end of therapy. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Weeks 1, 8, 12, end of therapy, Week 16, and follow-up ]

Enrollment: 7
Study Start Date: April 2003
Study Completion Date: May 2004
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647907


Locations
Taiwan
Pfizer Investigational Site
Kaohsiung, Taiwan
Pfizer Investigational Site
Taichung, Taiwan, 40705
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taipei, Taiwan, 114
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00647907     History of Changes
Other Study ID Numbers: A1501018
First Submitted: March 27, 2008
First Posted: April 1, 2008
Last Update Posted: May 16, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Cryptococcosis
Candidiasis
Mycoses
Aspergillosis
Invasive Fungal Infections
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors