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

Phase 1

• Conditions: Invasive Fungal Infections; MedDRA version: 19.1Level: PTClassification code 10017533Term: Fungal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000501-20-Outside-EU/EEA
• Lead Sponsor: Pfizer, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-09
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

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

Inclusion Criteria

1. Male or female subjects of age 2 years or older.
2. High-risk subjects with proven, probable or possible invasive fungal infection (IFI) according to the European Organization for the Research and Treatment of Cancer or Mycoses Study Group (EORTC or MSG) criteria.
3. Subjects indicated for secondary prophylaxis of invasive aspergillosis.

Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

1. Subjects with known hypersensitivity to Voriconazole or to any of the excipients.
2. Subjects with concomitant medications as follows:
•Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine.
•Coadministration of VFEND with rifampicin, carbamazepine and phenobarbital.
•Coadministration of standard doses of VFEND® with efavirenz.
•Coadministration of VFEND with high dose ritonavir (400mg and above twice daily).
•Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates.
•Coadministration of VFEND and sirolimus.
3. Children less than 2 years of age
4. Females with Pregnancy and lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified