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    Clinical Trial Results:
    Concentración y actividad antibiótica en soluciones de sellado

    Summary
    EudraCT number
    		 2010-023814-29
    Trial protocol
    		 ES  
    Global end of trial date
    28 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2021
    First version publication date
    26 Nov 2021
    Other versions
    Summary report(s)
    		 Final report summary

    Trial information

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    Trial identification
    Sponsor protocol code
    CAS110775 (CONAN)
    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, Clínica Universidad de Navarra - UCEC, 34 948255 400, ucicec@unav.es
    Scientific contact
    UCEC, Clínica Universidad de Navarra - UCEC, 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
    28 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Conocer a lo largo del tiempo la concentración de Vancomicina, Teicoplanina, Linezolid, Daptomicina y Tigeciclina en soluciones de sellado aplicados in vivo
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Dec 2011
    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: 93
    Worldwide total number of subjects
    93
    EEA total number of subjects
    93
    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)
    63
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Over a study period of 32 months, a total of 484 consecutive patients were assessed for eligibility (Figure 1). By the end of the study, a total of ninety-three patients have been randomized to the ALS groups

    Pre-assignment
    Screening details
    		 Over a study period of 32 months, a total of 484 consecutive patients were assessed for eligibility (Figure 1). By the end of the study, a total of ninety-three patients have been randomized to the ALS groups

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ALS group vancomycin
    Arm description
    		 Eleven patients to receive vancomycin
    Arm type
    		 Experimental

    Investigational medicinal product name
    vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms. ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline. All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.

    Arm title
    		 ALS group teicoplanin
    Arm description
    		 twenty-four patients to teicoplanin
    Arm type
    		 Experimental

    Investigational medicinal product name
    teicoplanin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms. ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline. All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.

    Arm title
    		 ALS group linezolid
    Arm description
    		 ten patients to linezolid
    Arm type
    		 Experimental

    Investigational medicinal product name
    linezolidrr
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms. ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline. All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.

    Arm title
    		 ALS group daptomycin
    Arm description
    		 twenty-six patients to daptomycin
    Arm type
    		 Experimental

    Investigational medicinal product name
    daptomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms. ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline. All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.

    Arm title
    		 ALS group tigecycline
    Arm description
    		 twenty-two patients to receive tigecycline
    Arm type
    		 Experimental

    Investigational medicinal product name
    tigecycline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Route of administration not applicable
    Dosage and administration details
    The antimicrobial lock technique (ALT) consists of the infusion of a highly concentrated antimicrobial solution into the catheter lumen to achieve the eradication of microorganisms. ALS groups: Eleven patients to receive vancomycin, twenty-four patients to teicoplanin, ten patients to linezolid, twenty-six patients to daptomycin, and twenty-two patients to receive tigecycline. All lock solutions were composed by heparin and an antimicrobial to achieve a concentration of vancomycin 2 mg/ml, teicoplanin 10 mg/ml, linezolid 1.8 mg/ml, daptomycin 5 mg/ml, and tigecycline 4.5 mg/ml.

    Number of subjects in period 1
    		ALS group vancomycin ALS group teicoplanin ALS group linezolid ALS group daptomycin ALS group tigecycline
    Started
    11
    24
    10
    26
    22
    Completed
    11
    24
    10
    26
    22

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    ALS group vancomycin
    Reporting group description
    		 Eleven patients to receive vancomycin

    Reporting group title
    ALS group teicoplanin
    Reporting group description
    		 twenty-four patients to teicoplanin

    Reporting group title
    ALS group linezolid
    Reporting group description
    		 ten patients to linezolid

    Reporting group title
    ALS group daptomycin
    Reporting group description
    		 twenty-six patients to daptomycin

    Reporting group title
    ALS group tigecycline
    Reporting group description
    		 twenty-two patients to receive tigecycline

    Primary: Time when the intraluminal concentration decreased below 1 mg/ml

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    End point title
    		 Time when the intraluminal concentration decreased below 1 mg/ml [1]
    End point description
    The treatment of each patient will last between 1 and 10 days.
    End point type
    Primary
    End point timeframe
    10 days
    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: The Kruskal-Wallis test was used to compare the antimicrobial concentrations among the groups. The Wilcoxon test was used to compare the antimicrobial concentrations at the end of dwelling time with the concentrations administered. Statistical significance was established at an alpha value of .05. All P values were two-tailed. The statistical analyses were performed using SPSS version 15.0.1 software (SPSS Inc., Chicago, IL, USA).
    End point values
    		 ALS group vancomycin ALS group teicoplanin ALS group linezolid ALS group daptomycin ALS group tigecycline
    Number of subjects analysed
    11
    24
    10
    26
    22
    Units: Days
        number (not applicable)
    11
    24
    10
    26
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AAs will be collected from the moment the patient signs the Informed Consent (IC) until 3 days after the administration of the last dose of the investigational drug and / or the last visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    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: The information will be updated as soon as available

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2012
    Protocol changes (concentrations, safety assessment, visit schedule)
    05 Jul 2012
    Change of sponsor
    04 Sep 2012
    Changes in inclusion criteria
    26 Mar 2013
    Change of the person pharmacovigilance responsible and other relevant protocol changes such as replacement criteria and changes with samples
    27 Oct 2014
    suspension of the tigecycline treatment arm

    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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    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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