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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01137292
First received: June 2, 2010
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Invasive Fungal Infections
Drug: voriconazole (VFEND®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement.


Enrollment: 177
Study Start Date: April 2007
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Active Treatment
Patients who are eligible for voriconazole treatment according to their physician decision.
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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female patients older than 2 years with invasive fungal infections.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137292

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01137292     History of Changes
Other Study ID Numbers: A1501082
Study First Received: June 2, 2010
Results First Received: July 12, 2010
Last Updated: August 31, 2011
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:
observational study
voriconazole
high-risk patients

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014