E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Invasive Fungal Infections |
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E.1.1.1 | Medical condition in easily understood language |
Evaluation of safety and ability of Voriconazole in treatment of fungal infections |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017533 |
E.1.2 | Term | Fungal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to collect data on treatment outcomes (clinical and mycological cure), safety and tolerability of treatment with Voriconazole in patients with invasive fungal infections in Slovakia. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects of age 2 years or older.
2. High-risk subjects with proven, probable or possible invasive fungal infection (IFI) according to the European Organization for the Research and Treatment of Cancer or Mycoses Study Group (EORTC or MSG) criteria.
3. Subjects indicated for secondary prophylaxis of invasive aspergillosis.
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E.4 | Principal exclusion criteria |
1. Subjects with known hypersensitivity to Voriconazole or to any of the excipients.
2. Subjects with concomitant medications as follows:
• Coadministration of the CYP3A4 substrates, terfenadine, astemizole, cisapride, pimozide or quinidine.
• Coadministration of VFEND with rifampicin, carbamazepine and phenobarbital.
• Coadministration of standard doses of VFEND® with efavirenz.
• Coadministration of VFEND with high dose ritonavir (400mg and above twice daily).
• Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are CYP3A4 substrates.
• Coadministration of VFEND and sirolimus.
3. Children less than 2 years of age
4. Females with Pregnancy and lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
Up to 2 weeks (EOT visit)
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Up to 2 weeks (Test-of-Cure visit)
Number of Subjects With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Up to 2 weeks (EOT visit)
Number of Subjects With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Up to 2 weeks (EOT visit) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit
Up to 2 weeks (EOT visit)
Number of Subjects With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit
Up to 2 weeks (Test-of-Cure visit)
Number of Subjects With Investigator's Satisfaction With the Efficacy of Voriconazole Assessment at the EOT Visit
Up to 2 weeks (EOT visit)
Number of Subjects With Investigator's Satisfaction With the Tolerability of Voriconazole Assessment at the EOT Visit
Up to 2 weeks (EOT visit)
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 5 |