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

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NCT00647907

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kaohsiung, , Taiwan
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidiasis, Cryptococcosis, Aspergillosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Liver function test abnormalities

- Renal disease

- Fungal infections not considered to be invasive or systemic

NCT00647907
Pfizer
Completed
A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections

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A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
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
The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Candidiasis
  • Cryptococcosis
  • Aspergillosis
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.
Experimental: A
Intervention: Drug: Voriconazole
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
May 2004
Not Provided

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00647907
A1501018
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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