Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection (Ve-RIFI)

Pfizer

Status: Completed

Conditions: Invasive Fungal Infections

Treatments: Drug: voriconazole (VFEND®)

Study type: Observational

Funder types: Industry

Identifiers

NCT01137292

A1501082

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

177 participants in 1 patient group

Active Treatment

Description:

Patients who are eligible for voriconazole treatment according to their physician decision.

Treatment:

Drug: voriconazole (VFEND®)