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

NCT01137292 | Completed Results

• 1 other identifier: A1501082
• Study Type: observational
• Target: 177
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Invasive Fungal Infections

Keywords

observational study; voriconazole; high-risk patients

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Active Treatment

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

Drug: voriconazole (VFEND®)

Interventions

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.

Active Treatment

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Invasive Fungal Infections

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: September 2, 2011
• Results First Posted: August 11, 2010

Record last verified: 2011-08