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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Invasive Fungal Infections Bacterial Infections and Mycoses Infections Mycoses

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

voriconazole (VFEND®)

Drug

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.

Primary outcomes

Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit

Time frame: up to 2 weeks (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.
Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit

Time frame: more than 2 weeks (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.
Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit

Time frame: up to 2 weeks (EOT visit)

Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.
Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit

Time frame: up to 2 weeks (EOT visit)

Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: Ve-RIFI

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 4, 2010
Registry last updated: Sep 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed