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

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647907
• Other study ID #: A1501018
• Status: Completed
• Phase: Phase 4
• First received: March 27, 2008
• Last updated: May 12, 2011
• Start date: April 2003
• Est. completion date: May 2004

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health, Executive Yuan
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Candidiasis
• Cryptococcosis
• Mycoses

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Change from baseline in electrocardiogram at Week 1 and end of therapy.		Week 1 and end of therapy	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

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