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

PHASE4CompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

April 30, 2003

Study Completion Date

May 31, 2004

Conditions
CandidiasisCryptococcosisAspergillosis
Interventions
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.

Trial Locations (4)

100

Pfizer Investigational Site, Taipei

114

Pfizer Investigational Site, Taipei

40705

Pfizer Investigational Site, Taichung

Unknown

Pfizer Investigational Site, Kaohsiung City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00647907 - A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections | Biotech Hunter | Biotech Hunter