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

Phase 4CompletedNCT00647907

Pfizer7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Candidiasis Cryptococcosis Aspergillosis

Interventions

VoriconazoleDRUG

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

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (4)

Pfizer Investigational Site

Kaohsiung City, Taiwan

Pfizer Investigational Site

Taichung, Taiwan

Pfizer Investigational Site

Taipei, Taiwan

Pfizer Investigational Site

Taipei, Taiwan

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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