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Trial record 1 of 1 for:    NCT01137292
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Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection (Ve-RIFI)

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ClinicalTrials.gov Identifier: NCT01137292
Recruitment Status : Completed
First Posted : June 4, 2010
Results First Posted : August 11, 2010
Last Update Posted : September 2, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 2, 2010
First Posted Date June 4, 2010
Results First Submitted Date July 12, 2010
Results First Posted Date August 11, 2010
Last Update Posted Date September 2, 2011
Study Start Date April 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2010)
  • 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.
Original Primary Outcome Measures
 (submitted: June 3, 2010)
  • To collect data on clinical cure of treatment with voriconazole in patients with invasive fungal infections in Slovakia [ Time Frame: At Last Subject Last Visit, November 2009 ]
  • To collect data on mycological cure of treatment with voriconazole in patients with invasive fungal infections in Slovakia [ Time Frame: At Last Subject Last Visit, November 2009 ]
  • To collect data on safety of treatment with voriconazole in patients with invasive fungal infections in Slovakia [ Time Frame: At Last Subject Last Visit, November 2009 ]
  • To collect data on tolerability of treatment with voriconazole in patients with invasive fungal infections in Slovakia [ Time Frame: At Last Subject Last Visit, November 2009 ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: June 3, 2010)
  • Incidence of risk factors for invasive fungal infection development [ Time Frame: At Last Subject Last Visit, November 2009 ]
  • Diagnostic procedures used in the management of invasive fungal infections [ Time Frame: At Last Subject Last Visit, November 2009 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Official Title Voriconazole In High-Risk Patients With Invasive Fungal Infections In Slovakia. An Open, Prospective, Non-Comparative Study
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Male or female patients older than 2 years with invasive fungal infections.
Condition Invasive Fungal Infections
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.
Study Groups/Cohorts Active Treatment
Patients who are eligible for voriconazole treatment according to their physician decision.
Intervention: Drug: voriconazole (VFEND®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 3, 2010)
177
Original Actual Enrollment Same as current
Actual Study Completion Date November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01137292
Other Study ID Numbers A1501082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2011