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    Clinical Trial Results:
    Voriconazole in High-Risk Patients With Invasive Fungal Infections in Slovakia. An Open, Prospective, Non-Comparative Study. (Ve-RIFI)

    Summary
    EudraCT number
    2017-000501-20
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    16 Nov 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Jun 2017
    First version publication date
    09 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A1501082
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01137292
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Apr 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To collect data on treatment outcomes (clinical and mycological cure), safety and tolerability of treatment with voriconazole in subjects with invasive fungal infections in Slovakia.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Apr 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 177
    Worldwide total number of subjects
    177
    EEA total number of subjects
    177
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    3
    Children (2-11 years)
    8
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    134
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    The study was conducted from 12 April 2007 to 16 November 2009 in Slovakia.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Voriconazole
    Arm description
    Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Voriconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received Voriconazole at a loading dose of 6 mg/kg every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg or 200 mg twice daily up to 2 weeks.

    Investigational medicinal product name
    Voriconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects weighing >40 kg, received formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing <40 kg received formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks.

    Number of subjects in period 1
    Voriconazole
    Started
    177
    Completed
    123
    Not completed
    54
         Death
    30
         Adverse event
    3
         Lack of efficacy
    13
         Other unspecified
    7
         Lost to follow-up
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks.

    Reporting group values
    Voriconazole Total
    Number of subjects
    177 177
    Age Categorical
    Units: Subjects
        <2 years
    3 3
        2 to 18 years
    16 16
        19 to 44 years
    52 52
        45 to 64 years
    80 80
        >=65 years
    26 26
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.9 ± 19.1 -
    Gender, Male/Female
    Units: Subjects
        Female
    73 73
        Male
    104 104

    End points

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    End points reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks.

    Primary: Number of Subjects With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit

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    End point title
    Number of Subjects With Clinical and/or Mycological Efficacy by Response at the End of Treatment (EOT) Visit [1]
    End point description
    Clinical, mycological responses: clinical cure, clinical improvement, no clinical cure, mycological cure, no mycological cure and no mycological culture performed. Subjects could have more than one responses. 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. Full analysis set (FAS) included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available.
    End point type
    Primary
    End point timeframe
    Baseline up to 2 Weeks (EOT visit)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed in this end point.
    End point values
    Voriconazole
    Number of subjects analysed
    177
    Units: subjects
        Clinical Cure
    64
        Clinical Improvement
    64
        No Clinical Cure
    36
        Mycological Cure
    34
        No Mycological Cure
    10
        No Mycological Culture Performed
    40
    No statistical analyses for this end point

    Primary: Number of Subjects With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit

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    End point title
    Number of Subjects With Clinical and/or Mycological Efficacy by Response at the Test-of-Cure Visit [2]
    End point description
    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. Subjects could have more than one responses. 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. FAS included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available.
    End point type
    Primary
    End point timeframe
    6 weeks after last dose of study drug
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed in this end point.
    End point values
    Voriconazole
    Number of subjects analysed
    177
    Units: subjects
        Clinical Cure
    54
        Clinical Improvement
    46
        No Clinical Cure
    7
        Mycological Cure
    31
        No Mycological Cure
    1
        No Mycological Culture Performed
    19
        Death
    41
        Lost From Follow-Up
    11
    No statistical analyses for this end point

    Primary: Number of Subjects With Investigator's Satisfaction with the Efficacy of Voriconazole Assessment at the End of Treatment (EOT) Visit

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    End point title
    Number of Subjects With Investigator's Satisfaction with the Efficacy of Voriconazole Assessment at the End of Treatment (EOT) Visit [3]
    End point description
    Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. FAS included all enrolled subjects who were administered the study medication and had post baseline documentation of efficacy available. Here, 'number of subjects analyzed' signifies the subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline up to 2 weeks (EOT visit)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed in this end point.
    End point values
    Voriconazole
    Number of subjects analysed
    172
    Units: subjects
        Very Good
    85
        Good
    49
        Moderate
    33
        Poor
    5
    No statistical analyses for this end point

    Primary: Number of Subjects With Investigator's Satisfaction with the Tolerability of Voriconazole Assessment at the End of Treatment (EOT) Visit

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    End point title
    Number of Subjects With Investigator's Satisfaction with the Tolerability of Voriconazole Assessment at the End of Treatment (EOT) Visit [4]
    End point description
    Investigator's Satisfaction Responses: very good, good, moderate, poor. Responses were based on the investigator's judgement. Safety population included subjects who received at least 1 dose of the study medication. Here, 'number of subjects analyzed' signifies the subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline up to 2 weeks (EOT visit)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive analysis was planned to be analysed in this end point.
    End point values
    Voriconazole
    Number of subjects analysed
    174
    Units: subjects
        Very Good
    105
        Good
    61
        Moderate
    8
        Poor
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after the last dose of study drug
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects received Voriconazole intravenously at a loading dose of 6 milligram per kilogram (mg/kg) every 12 hours (during the first 24 hours) followed by the maintenance dose of 4 mg/kg twice daily up to 2 weeks. Subjects weighing greater than (>) 40 kg, received oral formulation at a loading dose of 400 mg twice during the first 24 hours followed by maintenance dose of 200 mg twice daily up to 2 weeks. Subjects weighing less than (<) 40 kg received oral formulation at a loading dose of 200 mg twice during the first 24 hours followed by maintenance dose of 100 mg twice daily up to 2 weeks. Paediatric subjects <12 years received 7 mg/kg intravenously or 200 mg orally twice daily up to 2 weeks.

    Serious adverse events
    Voriconazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 177 (19.21%)
         number of deaths (all causes)
    41
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Multiple injuries
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 177 (1.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Subdural haematoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Traumatic brain injury
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lymphocytic leukaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Neoplasm
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasm malignant
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Non-Hodgkin’s lymphoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac failure
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 177 (2.82%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    Cardiopulmonary failure
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 177 (2.26%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory failure
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 177 (1.69%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    Blood and lymphatic system disorders
    Bone marrow disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pancytopenia
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    Haemorrhage intracranial
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 177 (1.69%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    Haemorrhagic stroke
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Locked-in syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Disease progression
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Multi-organ failure
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 177 (4.52%)
         occurrences causally related to treatment / all
    0 / 12
         deaths causally related to treatment / all
    0 / 6
    Sudden death
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Crush syndrome
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nephropathy toxic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Aspergillosis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 177 (2.82%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    Sepsis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 177 (2.26%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    Septic shock
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 177 (1.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Voriconazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 177 (3.39%)
    Vascular disorders
    Hypertensive crisis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Immune system disorders
    Hypersensitivity
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Hepatobiliary disorders
    Liver disorder
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acrodermatitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Rash pruritic
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 177 (0.56%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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