Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Fungal Infections
Intervention: voriconazole (VFEND®) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
Clinical Details
Official title: Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) VisitNumber of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: April 2007
Last updated: August 31, 2011
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