N/A
N=177
Open, Non Comparative Study Of Voriconazole In Slovak Patients With Very High Risk Of Developing An Invasive Fungal Infection
Invasive Fungal Infections
Bottom Line
View on ClinicalTrials.gov: NCT01137292 ↗Enrolled (actual)
177
Serious AEs
19.2%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit — 64; 64; 36; 34 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- voriconazole (VFEND®) (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit |
64; 64; 36; 34; 10; 40 | — |
| PRIMARY Number of Participants With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit |
54; 46; 7; 31; 1; 19 | — |
| PRIMARY Number of Participants With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit |
85; 49; 33; 5 | — |
| PRIMARY Number of Participants With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit |
105; 61; 8; 0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01137292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.