Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection

Completed

• Conditions: Invasive Fungal Infections
• Interventions: Drug: voriconazole (VFEND®)

• Registration Number: NCT01137292
• Lead Sponsor: Pfizer

Brief Summary

Assessment of safety and efficacy of voriconazole in real-life setting in the treatment of high risk patients with invasive fungal infections. The study is conducted in Slovakia only.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Results First Submitted: 2010-07-12
• Results First Submitted QC: 2010-07-15
• Results First Posted: 2010-08-11
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-31
• Last Update Posted: 2011-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Male or female patient of age 2 years or older.
• High-risk patients with proven, probable or possible invasive fungal infection (IFI) according to the EORTC/MSG criteria.
• Patients indicated for secondary prophylaxis of invasive aspergillosis.

Exclusion Criteria

• Patients with known hypersensitivity to voriconazole or to any of the excipients.
• Patients with contraindicated concomitant medications according to the SmPC.
• Children less than 2 years of age.
• Pregnancy and lactation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Treatment	voriconazole (VFEND®)	Patients who are eligible for voriconazole treatment according to their physician decision.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit	up to 2 weeks (EOT visit)	Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit	more than 2 weeks (Test-of-Cure visit)	Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit	up to 2 weeks (EOT visit)	Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit	up to 2 weeks (EOT visit)	Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.