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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) Visit

Number 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

Page last updated: August 23, 2015

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