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    Clinical Trial Results:
    Estudio de la eficacia de la administración prolongada de antibióticos betalactámicos frente a la administración intermitente en el tratamiento de la infección causada por microorganismo sensibles pero con concentraciones mínimas inhibitorias altas

    Summary
    EudraCT number
    		 2010-024117-31
    Trial protocol
    		 ES  
    Global end of trial date
    10 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2021
    First version publication date
    25 Nov 2021
    Other versions
    Summary report(s)
    		 APROVECHA publication

    Trial information

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    Trial identification
    Sponsor protocol code
    APROBECHA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clínica Universidad de Navarra
    Sponsor organisation address
    Avda. Pío XII, 36, Pamplona, Spain, 31008
    Public contact
    UCEC (ucicec@unav.es), Clínica Universidad de Navarra, 34 948255 400, ucicec@unav.es
    Scientific contact
    UCEC (ucicec@unav.es), Clínica Universidad de Navarra, 34 948255 400, ucicec@unav.es
    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
    13 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Comparar los parámetros farmacocinéticos/farmacodinámicos (PK/PD) de los betalactámicos en infusión prolongada con los de betalactámicos en infusión intermitente
    Protection of trial subjects
    The patients participating in the study consented after adequate information about the study. After inclusion, they were under the surveillance of the investigated team, among whose members were the infectious diseases area staff of the center, so they continued to receive the assistance that their clinical situation required. No other health protection measures were necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2012
    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
    Spain: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    1
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 3 patients were examined and finally included in the study. All of them gave their written consent to participate in the study. Two of the patients were randomized to receive beta-lactam in the experimental group, while the third patient participated in the control group.

    Pre-assignment
    Screening details
    		 Before the treatment was assigned, the presence of an infectious process was verified with the isolation of a microorganism with a MIC close to the reference cut-off point according to the CLSI (1-2 dilutions). In all cases, Pseudomonas aeruginosa was isolated in the evaluated samples, with a MIC between 8 and 16 for piperacillin-tazobactam.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 patients with a beta-lactam antibiotic in intermittent infusion following the classic administration guidelines
    Arm type
    		 Active comparator

    Investigational medicinal product name
    beta-lactams
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    In all cases, the drug was administered diluted in a volume of 100 ml of physiological saline. Administration according to the classical regimen involves administration of the product as a short 30-minute intravenous infusion.

    Arm title
    		 Treatment
    Arm description
    		 Experimental arm, patients with a beta-lactam antibiotic in prolonged infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    beta-lactams
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    In all cases, the drug was administered diluted in a volume of 100 ml of physiological saline. La administración prolongada suponía la administración del producto en una infusión de 240 minutos.

    Number of subjects in period 1
    		Control Treatment
    Started
    1
    2
    Completed
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Total
    Number of subjects
    		 3 3
    Age categorical
    Units: Subjects
        > 18 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 patients with a beta-lactam antibiotic in intermittent infusion following the classic administration guidelines

    Reporting group title
    Treatment
    Reporting group description
    		 Experimental arm, patients with a beta-lactam antibiotic in prolonged infusion.

    Primary: Difference between long infusion and intermittent infusion

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    End point title
    		 Difference between long infusion and intermittent infusion [1]
    End point description
    After steady equilibrium was reached, blood samples were drawn to measure beta-lactam concentrations. The extractions were carried out in the stipulated times, obtaining the concentrations (µg / ml) of piperacillin
    End point type
    Primary
    End point timeframe
    Day of extraaction: Extraction in 30 minutes, 1 hour, 2 hours, 4 hours
    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: It was not possible to perform any analysis of the results, given the low number of patients included in the study. The data of the three patients are presented in a descriptive way.
    End point values
    		 Control Treatment
    Number of subjects analysed
    1
    2
    Units: Hours
        number (not applicable)
    1
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2012
    Changes in protocol and patient information sheet
    23 Apr 2013
    Changes in inclusion criteria

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Jun 2014
    Inability to recruit patients
    -

    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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    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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