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

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

Official Title
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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

Conditions
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Candidiasis, Cryptococcosis, Aspergillosis

Intervention / Treatment
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* Drug: Voriconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Voriconazole<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |