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

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NCT00647907

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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

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Candidiasis, Cryptococcosis, AspergillosisA Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
NCT00647907
  1. Kaohsiung,
  2. Taichung,
  3. Taipei,
  4. Taipei,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Voriconazole for the Treatment of Fungal Infections
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the efficacy and safety of Vfend for the treatment of fungal infections
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Candidiasis
  • Cryptococcosis
  • Aspergillosis
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: A
Intervention: Drug: Voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2011)		7
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2008)		20
Actual Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647907
Other Study ID Numbers  ICMJE A1501018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP