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    Clinical Trial Results:
    Efficacy of short duration sequential therapy versus standard intravenous therapy for patients with uncomplicated catheter related bacteremia due to S. aureus methicillin-susceptible.

    Summary
    EudraCT number
    		 2013-000511-24
    Trial protocol
    		 ES  
    Global end of trial date
    10 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2021
    First version publication date
    01 Apr 2021
    Other versions
    Summary report(s)
    		 Final report of results

    Trial information

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    Trial identification
    Sponsor protocol code
    FPS-COL-2013-06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fundación Pública Andaluza Progreso y Salud
    Sponsor organisation address
    Parque Científico y Tecnológico Cartuja, Avda. Américo Vespucio, 15. Edificio S-2. 41092 Sevilla, Seville, Spain, 41092
    Public contact
    Maria del Mar Benjumea Vargas, FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD, 0034 955040460, maria.benjumea@juntadeandalucia.es
    Scientific contact
    Maria del Mar Benjumea Vargas, FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD, 0034 955040460, maria.benjumea@juntadeandalucia.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
    10 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assess the eficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin susceptible, selected based on a set of pre-established criteria equals the pattern of the conventional intravenous
    Protection of trial subjects
    This trial should be conducted in accordance with the protocol following the sponsor's SOPs. The trial shall be conducted in accordance with the recommendations for Clinical Trials and Investigational Product Evaluation in Man, as contained in the Declaration of Helsinki, as revised at successive World Assemblies (WMA, 2008), and the current Spanish Clinical Trial Legislation (RD 223/2004). The ICH-GCP standards (CPMP/ICH/135/95) will be followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2013
    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: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with uncomplicated catheter-associated bacteraemia due to methicillin-sensitive S. aureus, ≥ 18 years with a minimum weight of 40 kg.

    Pre-assignment
    Screening details
    		 Patients with uncomplicated catheter-associated bacteraemia due to methicillin-sensitive S. aureus, ≥ 18 years with a minimum weight of 40 kg.

    Period 1
    Period 1 title
    Recruitment and follw-up
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levofloxacino
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Compressed lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    cloxacillin 2g/4 hours i.v., 5 days followed by levofloxacin 500 mg v.o. /24h, 9 days.

    Investigational medicinal product name
    Cloxacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    cloxacillin 2g/4 hours i.v., 5 days followed by levofloxacin 500 mg v.o. /24h, 9 days.

    Number of subjects in period 1
    		Experimental
    Started
    1
    Completed
    1
    Period 2
    Period 2 title
    Data analysis
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Levofloxacino
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Compressed lozenge
    Routes of administration
    Oral use
    Dosage and administration details
    cloxacillin 2g/4 hours i.v., 5 days followed by levofloxacin 500 mg v.o. /24h, 9 days.

    Investigational medicinal product name
    Cloxacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    cloxacillin 2g/4 hours i.v., 5 days followed by levofloxacin 500 mg v.o. /24h, 9 days.

    Number of subjects in period 2
    		Experimental
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment and follw-up
    Reporting group description
    		 Only one patient was recruited in the clinical trial

    Reporting group values
    		 Recruitment and follw-up Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 1 1

    End points

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

    Primary: Failure rate

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    End point title
    		 Failure rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    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 one patient was enrolled in this clinical trial. Statistical analysis could not be performed due to insufficient data.
    End point values
    		 Experimental
    Number of subjects analysed
    1
    Units: death or complications
        no death or complications
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Serious adverse events
    		 Experimental
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Experimental
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (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: No adverse events were reported in the only clinical trial participant.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jul 2013
    Change in the number of visits during the trial, in addition to the elimination of one site that did not receive a favourable opinion from its local committee, and the separation of two annexes from the protocol because they were considered independent documents.

    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.
    Only one patient was enrolled in the clinical trial and therefore, results could not be achieved.
    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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