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

Invasive Fungal Infections Clinical Trial

— Ve-RIFI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137292
• Other study ID #: A1501082
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: August 31, 2011
• Start date: April 2007
• Est. completion date: November 2009

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Invasive Fungal Infections
• Mycoses

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit	Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, and no mycological culture performed. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.	up to 2 weeks (EOT visit)	No
Primary	Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit	Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure, no mycological culture performed, death, and lost from follow-up. Participants could have had more than one response. Responses were based on the investigator's judgement according to the Infectious Disease Society of America, European Conference on Infections in Leukemia, and European Committee on Antimicrobial Susceptibility Testing guidelines.	more than 2 weeks (Test-of-Cure visit)	No
Primary	Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit	Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.	up to 2 weeks (EOT visit)	No
Primary	Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit	Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.	up to 2 weeks (EOT visit)	No

External Links

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