Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection (Ve-RIFI)

Active Treatment

Patients who are eligible for voriconazole treatment according to their physician decision.

Medicin: 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.

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.

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.

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.

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.