Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-comparative Study

Pfizer, Inc.0 个研究点目标入组 177 人开始时间: 2017年3月9日最近更新: 2017年4月3日

适应症

试验速览

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•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

•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

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