NCT01137292

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 177 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Invasive Fungal Infections

Interventions

Type	Name	Description
DRUG	voriconazole (VFEND®)	The use and dosage recommendations for voriconazole (VFEND®) will take place on the basis of the Summary of Product Characteristics (SmPC) and will be adjusted solely according to medical and therapeutic necessity. The formulation and dose will be managed by the treating physician according to the SmPC, disease and clinical situation. According to the SmPC, in the adults the treatment should be started with the loading dose of 6 mg/kg of voriconazole iv. every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg BID. For peroral formulations, the initial dose should be depending on the weight of the patient 400 mg or 200 mg BID during the first 24 hrs, followed by the maintenance dose of 200 mg or 100 mg of voriconazole BID respectively For paediatric population (\<12 years of age), there is no initial dose necessary. Depending on the formulation, the daily dosage should be in children 7 mg/kg iv. BID or 200 mg of voriconazole orally BID.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2010-06-04
• Last updated: 2011-09-02
• Results posted: 2010-08-11