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    Clinical Trial Results:
    WIRKORTKONZENTRATIONEN VON AMPHOTERICIN B FORMULIERUNGEN IN ASZITES, LIQUOR, PLEURAERGUSS, GALLE UND LIQUOR BEI KRITISCH KRANKEN (Target-site concentrations of Amphotericin B preparations in ascites, pleural effusion, bile and cerebrospinal fluid in critically ill patients)

    Summary
    EudraCT number
    		 2007-001795-37
    Trial protocol
    		 AT  
    Global end of trial date
    01 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2022
    First version publication date
    01 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AMB TS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Univ. Prof. Dr. Romuald Bellmann, University Hospital for Internal Medicine I, Anichstrasse 35, 6020 Innsbruck, +43 (0)512 504 24181, romuald.bellmann@tirol-kliniken.at
    Scientific contact
    Univ. Prof. Dr. Romuald Bellmann, University Hospital for Internal Medicine I, Anichstrasse 35, 6020 Innsbruck, +43 (0)512 504 24181, romuald.bellmann@tirol-kliniken.at
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Mar 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    to determine concentrations of amphotericin B in plasma and at target site (ascites, pleural effusion, bile and cerebrospinal fluid). to determine target-site penetration of amphotericin B preparatations administered in critically ill patients requiring a amphotericin B preparation.
    Protection of trial subjects
    As the body fluid samples were drawn during routine interventions, there was no additional risk for the patients
    Background therapy
    		 Subjects received treatment at the intensive care unit according to clinical requirements.
    Evidence for comparator
    		 There was no evidence for a comparator in this trial.
    Actual start date of recruitment
    20 Jul 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
    Austria: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    9
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Critically ill adult patients with a clinical indication for paracentesis (or peritoneal drainage), thoracentesis (or pleural drainage), lumbar puncture or bile deviation receiving treatment with lipid-formulated AmB for proven or suspected invasive fungal infection were enrolled.

    Pre-assignment
    Screening details
    		 Critically ill adult patients with a clinical indication for paracentesis (or peritoneal drainage), thoracentesis (or pleural drainage), lumbar puncture or bile deviation receiving treatment with lipid-formulated AmB for proven or suspected invasive fungal infection were enrolled.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ascites
    Arm description
    		 Determination of Amphotericin B levels in ascitic specimens using High Performance Liquid Chromatography
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphocil
    Investigational medicinal product code
    ABCD
    Other name
    Amphotericin B colloidal dispersion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABCD (Amphocil; Torrex-Chiesi Pharma, Vienna, Austria) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    LAMB
    Other name
    Liposomal Amphotericin B
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    LAMB (AmBisome; Gilead, San Dimas, CA), was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    Abelcet
    Investigational medicinal product code
    ABLC
    Other name
    Amphotericin B lipid complex
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABLC (Abelcet; Elan Pharma International Limited, Athlone, Ireland) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Arm title
    		 Pleural effusion
    Arm description
    		 Determination of Amphotericin B levels in pleural effusion specimens using High Performance Liquid Chromatography
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphocil
    Investigational medicinal product code
    ABCD
    Other name
    Amphotericin B colloidal dispersion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABCD (Amphocil; Torrex-Chiesi Pharma, Vienna, Austria) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    LAMB
    Other name
    Liposomal Amphotericin B
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    LAMB (AmBisome; Gilead, San Dimas, CA), was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    Abelcet
    Investigational medicinal product code
    ABLC
    Other name
    Amphotericin B lipid complex
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABLC (Abelcet; Elan Pharma International Limited, Athlone, Ireland) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Arm title
    		 Bile
    Arm description
    		 Determination of Amphotericin B levels in bile specimens using High Performance Liquid Chromatography
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amphocil
    Investigational medicinal product code
    ABCD
    Other name
    Amphotericin B colloidal dispersion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABCD (Amphocil; Torrex-Chiesi Pharma, Vienna, Austria) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    AmBisome
    Investigational medicinal product code
    LAMB
    Other name
    Liposomal Amphotericin B
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    LAMB (AmBisome; Gilead, San Dimas, CA), was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Investigational medicinal product name
    Abelcet
    Investigational medicinal product code
    ABLC
    Other name
    Amphotericin B lipid complex
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    ABLC (Abelcet; Elan Pharma International Limited, Athlone, Ireland) was dissolved as recommended by the manufacturers and administered intravenously at doses of 3 to 5 mg/kg of body weight over 4 h once a day.

    Number of subjects in period 1
    		Ascites Pleural effusion Bile
    Started
    3
    7
    4
    Completed
    3
    7
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ascites
    Reporting group description
    		 Determination of Amphotericin B levels in ascitic specimens using High Performance Liquid Chromatography

    Reporting group title
    Pleural effusion
    Reporting group description
    		 Determination of Amphotericin B levels in pleural effusion specimens using High Performance Liquid Chromatography

    Reporting group title
    Bile
    Reporting group description
    		 Determination of Amphotericin B levels in bile specimens using High Performance Liquid Chromatography

    Reporting group values
    		 Ascites Pleural effusion Bile Total
    Number of subjects
    		 3 7 4 14
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 2 4 3 9
        From 65-84 years
    		 1 3 1 5
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 57.67 (44 to 68) 54.57 (29 to 76) 58.5 (50 to 67) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 2 3
        Male
    		 3 6 2 11

    End points

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    End points reporting groups
    Reporting group title
    Ascites
    Reporting group description
    		 Determination of Amphotericin B levels in ascitic specimens using High Performance Liquid Chromatography

    Reporting group title
    Pleural effusion
    Reporting group description
    		 Determination of Amphotericin B levels in pleural effusion specimens using High Performance Liquid Chromatography

    Reporting group title
    Bile
    Reporting group description
    		 Determination of Amphotericin B levels in bile specimens using High Performance Liquid Chromatography

    Primary: Amphotericin B

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    End point title
    		 Amphotericin B [1]
    End point description
    Determination of Amphotericin B levels in ascitic, pleural effusion and bile specimens using High Performance Liquid Chromatography
    End point type
    Primary
    End point timeframe
    20.07.2007-01-03-2016
    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: Target-site concentration was the primary endpoint of this pharmacokinetic study: In pleural effusion samples, total AMB concentrations were significantly lower than the total concentrations in plasma samples (P = 0.03).
    End point values
    		 Ascites Pleural effusion Bile
    Number of subjects analysed
    3
    7
    4
    Units: µg/µL
        arithmetic mean (full range (min-max))
    0.31 (0.26 to 0.36)
    0.16 (0.02 to 0.43)
    0.63 (0.04 to 1.28)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    20.07.2007-01.03.2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    Ascites
    Reporting group description
    		 Determination of Amphotericin B levels in ascitic specimens using High Performance Liquid Chromatography

    Reporting group title
    Pleural effusion
    Reporting group description
    		 Determination of Amphotericin B levels in pleural effusion specimens using High Performance Liquid Chromatography

    Reporting group title
    Bile
    Reporting group description
    		 Determination of Amphotericin B levels in bile specimens using High Performance Liquid Chromatography

    Serious adverse events
    		 Ascites Pleural effusion Bile
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ascites Pleural effusion Bile
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 7 (0.00%)
    0 / 4 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Drawing blood from an arterial line, which is needed for ICU routine monitoring, is without significant additional risk.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Apr 2010
    University Hospital for Visceral, Transplant and Thoracic Surgery including ICU was opened for recruitment. Two new subinvestigators were delegated for this trial.
    19 Feb 2014
    For assessment of antifungal activity of AmB in patient bile samples, an ex vivo simulation was performed. Assessment was performed at the Institute of Hygiene and Medical Microbiology. Four new subinvestigators were delegated.
    28 Apr 2015
    Four ICUs at the Medical University Innsbruck were opened for recruitment. Four new subinvestigators were delegated.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/18662944
    http://www.ncbi.nlm.nih.gov/pubmed/17785511
    http://www.ncbi.nlm.nih.gov/pubmed/26119497
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