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    Clinical Trial Results:
    Eficacia y seguridad de Piperacilina/Tazobactam administrada en perfusión continua versus infusión intermitente en pacientes con infección complicada o nosocomial con sospecha o aislamiento de Pseudomonas aeruginosa.

    Summary
    EudraCT number
    		 2010-024606-34
    Trial protocol
    		 ES  
    Global end of trial date
    10 Sep 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    PiperTazo
    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
    Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, +34 955 04 04 50, gestionensayosclinicos.fps@juntadeandalucia.es
    Scientific contact
    Marta Reboredo Ares, Fundación Pública Andaluza Progreso y Salud, +34 955 04 04 50, gestionensayosclinicos.fps@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 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    verificar, que la administración de piperacilina/tazobactam en perfusión continua administrada para tratar infecciones complicadas o de origen nosocomial con sospecha o aislamiento de Pseudomonas aeruginosa es, superior en eficacia a una dosis un 30% superior administrada en infusión corta convencional.
    Protection of trial subjects
    The sponsor undertakes to ensure safety and to promptly report any information that could modify the risk/benefit ratio of piperacillin/tazobactam, or determine changes in the schedule of administration or conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 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: 78
    Worldwide total number of subjects
    78
    EEA total number of subjects
    78
    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)
    78
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Once the patient is eligible, meets the inclusion criteria, does not meet any exclusion criteria and signs the informed consent to participate in the clinical trial, randomisation will proceed.

    Pre-assignment
    Screening details
    		 Once the patient is eligible, meets the inclusion criteria, does not meet any exclusion criteria and signs the informed consent to participate in the clinical trial, randomisation will proceed.

    Period 1
    Period 1 title
    Recruitment and follow-up
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuous perfusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Piperacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    Initial dose of 2 of Piperacillin + 24-hour continuous infusion of 8 g Piperacillin in 500 mi of saline (NaCI 0.9%).

    Investigational medicinal product name
    Tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    Initial dose of 0.25 g of Tazobactam + 24-hour continuous infusion of 1 g Tazobactam in 500 mi of saline (NaCI 0.9%).

    Arm title
    		 Intermittent perfusion
    Arm description
    		 -
    Arm type
    		 Control

    Investigational medicinal product name
    Piperacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    4 g/100 mi of Piperacillin every 8 hours as a short infusion.

    Investigational medicinal product name
    Tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    0.5 g/100 mi of Tazobactam every 8 hours as a short infusion.

    Number of subjects in period 1
    		Continuous perfusion Intermittent perfusion
    Started
    40
    38
    Completed
    40
    38
    Period 2
    Period 2 title
    Data analysis
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Continuous perfusion
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Piperacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Other use
    Dosage and administration details
    Initial dose of 2 of Piperacillin + 24-hour continuous infusion of 8 g Piperacillin in 500 mi of saline (NaCI 0.9%).

    Investigational medicinal product name
    Tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    Initial dose of 0.25 g of Tazobactam + 24-hour continuous infusion of 1 g Tazobactam in 500 mi of saline (NaCI 0.9%).

    Arm title
    		 Intermittent perfusion
    Arm description
    		 -
    Arm type
    		 Control

    Investigational medicinal product name
    Piperacillin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    4 g/100 mi of Piperacillin every 8 hours as a short infusion.

    Investigational medicinal product name
    Tazobactam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Other use
    Dosage and administration details
    0.5 g/100 mi of Tazobactam every 8 hours as a short infusion.

    Number of subjects in period 2
    		Continuous perfusion Intermittent perfusion
    Started
    40
    38
    Completed
    40
    38

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Continuous perfusion
    Reporting group description
    		 -

    Reporting group title
    Intermittent perfusion
    Reporting group description
    		 -

    Reporting group values
    		 Continuous perfusion Intermittent perfusion Total
    Number of subjects
    		 40 38 78
    Age categorical
    Units: Subjects
        18 years and over
    		 40 38 78
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.30 ± 14.25 63.80 ± 17.25 -
    Gender categorical
    Units: Subjects
        Female
    		 16 16 32
        Male
    		 24 22 46
    Height
    Units: Metres
        arithmetic mean (standard deviation)
    		 1.66 ± 0.10 1.63 ± 0.12 -
    Weight
    Units: Kg
        arithmetic mean (standard deviation)
    		 74.34 ± 15.83 76.14 ± 15.90 -

    End points

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    End points reporting groups
    Reporting group title
    Continuous perfusion
    Reporting group description
    		 -

    Reporting group title
    Intermittent perfusion
    Reporting group description
    		 -
    Reporting group title
    Continuous perfusion
    Reporting group description
    		 -

    Reporting group title
    Intermittent perfusion
    Reporting group description
    		 -

    Primary: Clinical response at the end of treatment

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    End point title
    		 Clinical response at the end of treatment [1]
    End point description
    End point type
    Primary
    End point timeframe
    Throughout 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: Information is not available for some of the required fields. However, the final analysis of the results is attached where all the information of the statistical analysis appears.
    End point values
    		 Continuous perfusion Intermittent perfusion
    Number of subjects analysed
    40
    38
    Units: Participants
        healing
    31
    27
        failure
    7
    13
    No statistical analyses for this end point

    Primary: treatment time to cure

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    End point title
    		 treatment time to cure [2]
    End point description
    End point type
    Primary
    End point timeframe
    During the study
    Notes
    [2] - 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: Information is not available for some of the required fields. However, the final analysis of the results is attached where all the information of the statistical analysis appears.
    End point values
    		 Continuous perfusion Intermittent perfusion
    Number of subjects analysed
    40
    38
    Units: Days
        arithmetic mean (standard deviation)
    9.62 ± 0.64
    7.55 ± 0.76
    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
    17.0
    Reporting groups
    Reporting group title
    Both groups
    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 effects have been reported.
    Serious adverse events
    		 Both groups
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 78 (3.85%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Blood and lymphatic system disorders
    febrile neutropenia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    pancreatic neoplasm leading to death
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Both groups
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 78 (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
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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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