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    Clinical Trial Results:
    ABSORB 2:An exploratie study determining the oral antibiotic drug absorption in patients with short bowel syndrome.

    Summary
    EudraCT number
    		 2019-002587-28
    Trial protocol
    		 NL  
    Global end of trial date
    07 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2023
    First version publication date
    24 Aug 2023
    Other versions
    Summary report(s)
    		 Article

    Trial information

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    Trial identification
    Sponsor protocol code
    2019-5165
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Nederlands Trial Register: NL7796
    Sponsors
    Sponsor organisation name
    Radboud university medical center
    Sponsor organisation address
    Geert grooteplein zuid 10, Nijmegen, Netherlands, 6500HB
    Public contact
    Michelle Gompelman, Radboudumc, 31 243093767, Michelle.Gompelman@radboudumc.nl
    Scientific contact
    Michelle Gompelman, Radboudumc, 31 243093767, Michelle.Gompelman@radboudumc.nl
    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 Nov 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to determine the absorption of orally administered antibiotics in patients with SBS, to guide in clinical decision making when faced with catheter related infections.
    Protection of trial subjects
    In general, this study aims to restrict the physical and mental burdens for the subject as much as possible. The physical risks that are introduced by this study to the participants are believed to be minimal. The risk derives from collecting the blood are negligible if performed by well-trained physicians and/or nurses. Next to this, the antimicrobial agents as prescribed as a single dose, have the potential risk of developing side effects, certain toxicities and allergies or intolerance. These potential risks however, are low since only a single dosage is given and are mostly wellknown because the antibiotics are prescribed frequently. During the study, there will be sufficient medical health assistance (nurse practitioners, attending physician or principle investigator) present at all times in the hospital and reachable by phone to cope with unexpected events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2020
    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
    Netherlands: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants will be included at the outpatient clinic of the Radboudumc Gastroenterology and Hepatology department. Patients with an indication for HPN training or other intervention that requires elective admission without presence of exclusion criteria for the study will be asked by their treating physician to participate in the study.

    Pre-assignment
    Screening details
    		 Due to the explorative nature of the study, no blinding will be performed. After checking the inclusion- and exclusion criteria by the physician/principal investigator and informed consent is given, 8 patients are assigned to the CC-group and the other 8 patients to the FF-group.

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

    Arms
    Arm title
    		 Everyone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    fluconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension, Capsule
    Routes of administration
    Enteral use , Infusion
    Dosage and administration details
    Flucanozole 400mg IV and oral dose (suspension) is an antifungal agent belonging to the triazole class.

    Investigational medicinal product name
    Ciprofloxacin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Suspension for oral suspension
    Routes of administration
    Enteral use , Infusion
    Dosage and administration details
    Ciprofloxacin 750mg oral dose (suspension) and 400mg IV dose, is a fluoroquinolone antibiotic.

    Investigational medicinal product name
    Clindamycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Suspension for oral suspension
    Routes of administration
    Enteral use , Infusion
    Dosage and administration details
    Clindamycin 600mg IV and oral dose (suspension) belongs to the lincosamide class

    Investigational medicinal product name
    Flucloxacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Suspension for oral suspension
    Routes of administration
    Enteral use , Infusion
    Dosage and administration details
    Flucloxacillin 1000mg IV and oral dose (tablet/suspension) is a beta-lactam antibiotic.

    Number of subjects in period 1
    		Everyone
    Started
    18
    Completed
    18

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 -

    Reporting group values
    		 Full study Total
    Number of subjects
    		 18 18
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 9 9
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59 ( 17 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    full analysis

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    18
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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 65-84 years
    9
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    59 ( 17 )
    Gender categorical
    Units: Subjects
        Female
    10
        Male
    8

    End points

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    End points reporting groups
    Reporting group title
    Everyone
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    full analysis

    Primary: Oral bioavailability

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    End point title
    		 Oral bioavailability [1]
    End point description
    End point type
    Primary
    End point timeframe
    Oral bioavailability of ciprofloxacin, clindamycin, flucloxacillin and fluconazole in patients with SBS.
    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: Please see article voor statistical analysis
    End point values
    		 Everyone Full analysis
    Number of subjects analysed
    18
    18
    Units: %
        number (not applicable)
    18
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    We reported the adverse events after adverse event on toetsing online.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Everyone
    Reporting group description
    		 -

    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: No non-serious adverse events
    Serious adverse events
    		 Everyone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Inguinal pain
    Additional description: During the study, one female participant developed severe inguinal pain. The diagnosis was a psoas hematoma following a fall a few days before while having a dysregulated (high) anticoagulant (warfarin) level.
         subjects affected / exposed [2]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Everyone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 18 (0.00%)

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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