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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01137292
Other study ID # A1501082
Secondary ID
Status Completed
Phase N/A
First received June 2, 2010
Last updated August 31, 2011
Start date April 2007
Est. completion date November 2009

Study information

Verified date August 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Slovakia: State Institute for Drug Control
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 177
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Primary 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) No
Primary 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) No
Primary 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) No
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