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Completed

NCT Number: NCT00647907

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

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

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Key information

Conditions

Candidiasis Aspergillosis Bacterial Infections and Mycoses Cryptococcosis Infections Mycoses

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voriconazole

Drug

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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

  3. Change from baseline in electrocardiogram at Week 1 and end of therapy.

    Time frame: Week 1 and end of therapy

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Apr 1, 2008
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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