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”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A

Primary 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• 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
    Safety Issue?: Yes
• Change from baseline in electrocardiogram at Week 1 and end of therapy.
  • Time Frame: Week 1 and end of therapy
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00647907

Study ID Number: A1501018

ClinicalTrials.gov Identifier: NCT00647907

Health Authority: Taiwan: Department of Health, Executive Yuan

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