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    Clinical Trial Results:
    SOAP Antibiotic prophylaxis trial Systemic versus combined systemic and Oral Antibiotic Prophylaxis in elective colorectal surgery

    Summary
    EudraCT number
    		 2015-005614-30
    Trial protocol
    		 HU  
    Global end of trial date
    25 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2020
    First version publication date
    26 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOAP2016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Uzsoki Utcai Kórház, Surgical and Oncosurgical Ward
    Sponsor organisation address
    Róna str, Budapest, Hungary,
    Public contact
    Surgical and Oncosurgical Ward, Uzsoki Utcai Kórház, 36 146737003794, papgez@gmail.com
    Scientific contact
    Surgical and Oncosurgical Ward, Uzsoki Utcai Kórház, 36 146737003794, papgez@gmail.com
    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
    09 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This trial is designed to assess the benefit of oraly administred antibiotic prophylaxis beside bowelprep and venous antibiotic prophylaxis versus bowelprep and systemic antibiotic prophylaxis alone. The scope are postoperative and infective complications.
    Protection of trial subjects
    1. The current revision of the Declaration of Helsinki is the accepted as a basis for this trial ethics, and was fully followed and respected. 2. The trial has permission of National Institute of Pharmacy and Nutrition Health and of Medical Research Council of Hungary. 3. The principles of informed consent in the current revisions of the Declaration of Helsinki (Appendix 1) and the International Ethical Guidelines for Biomedical Research Involving Human Subjects (2) was implemented. 4. The investigators established secure safeguards of confidentiality of research data as described in the current revision of the International Ethical Guidelines for Biomedical Research Involving Human Subjects.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 600
    Worldwide total number of subjects
    600
    EEA total number of subjects
    600
    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)
    300
    From 65 to 84 years
    270
    85 years and over
    30

    Subject disposition

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    Recruitment
    Recruitment details
    		 Elective colorectal resections with planned anastomosis

    Pre-assignment
    Screening details
    		 Age over 18 No abdominal sepsis 6 month prior assignment No antibiotic therapy 2 weeks prior assignment Pregnancy Lactation Chronic immune supprimed Steroid use

    Period 1
    Period 1 title
    overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 OABP+
    Arm description
    		 Patients recieved TID metranidasol 500mg and TID neonycine sulphat 1000mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    metronidasol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Enteral use
    Dosage and administration details
    TID metranidasol 500mg

    Investigational medicinal product name
    neomycine sulphat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    TID neomycine sulphat 1000mg

    Arm title
    		 OABP-
    Arm description
    		 No oral antibiotic prophylaxis
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: 2 arms, randomised trial. Assessor was blind.
    Number of subjects in period 1
    		OABP+ OABP-
    Started
    298
    302
    Completed
    274
    302
    Not completed
    24
    0
         Adverse event, non-fatal
    7
    -
         Protocol deviation
    17
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall period
    Reporting group description
    		 -

    Reporting group values
    		 overall period Total
    Number of subjects
    		 600 600
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (standard deviation)
    		 66.3 ( 12.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 280 280
        Male
    		 320 320

    End points

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    End points reporting groups
    Reporting group title
    OABP+
    Reporting group description
    		 Patients recieved TID metranidasol 500mg and TID neonycine sulphat 1000mg

    Reporting group title
    OABP-
    Reporting group description
    		 No oral antibiotic prophylaxis

    Primary: SSI (surgical site infection)

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    End point title
    		 SSI (surgical site infection)
    End point description
    End point type
    Primary
    End point timeframe
    Within 30 days after recieving oral antibiotic prophylaxis
    End point values
    		 OABP+ OABP-
    Number of subjects analysed
    253
    276
    Units: number of patients
    8
    27
    Statistical analysis title
    		 z test
    Comparison groups
    OABP- v OABP+
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Primary: POI (postoperative ileus)

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    End point title
    		 POI (postoperative ileus)
    End point description
    End point type
    Primary
    End point timeframe
    30 days within recieving the oral antibiotic prophylaxis
    End point values
    		 OABP+ OABP-
    Number of subjects analysed
    253
    276
    Units: number of patients
    16
    16
    Statistical analysis title
    		 z test
    Comparison groups
    OABP+ v OABP-
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Regression, Linear
    Confidence interval

    Secondary: AI (Anastomos insufficiency)

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    End point title
    		 AI (Anastomos insufficiency)
    End point description
    End point type
    Secondary
    End point timeframe
    30 days within recieving the oral antibiotic prophylaxis
    End point values
    		 OABP+ OABP-
    Number of subjects analysed
    253
    276
    Units: Number of patients
    4
    13
    No statistical analyses for this end point

    Secondary: 30day readmission

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    End point title
    		 30day readmission
    End point description
    End point type
    Secondary
    End point timeframe
    30 days within recieving the oral antibiotic prophylaxis
    End point values
    		 OABP+ OABP-
    Number of subjects analysed
    253
    276
    Units: number of patients
    12
    10
    No statistical analyses for this end point

    Secondary: 30 day mortality

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    End point title
    		 30 day mortality
    End point description
    End point type
    Secondary
    End point timeframe
    30 days within recieving the oral antibiotic prophylaxis
    End point values
    		 OABP+ OABP-
    Number of subjects analysed
    253
    276
    Units: number of patients
    3
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 days within recieving the oral antibiotic prophylaxis
    Adverse event reporting additional description
    daily questionnaire
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    OABP+
    Reporting group description
    		 -

    Serious adverse events
    		 OABP+
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 274 (0.00%)
         number of deaths (all causes)
    3
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 OABP+
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 274 (10.58%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    29 / 274 (10.58%)
         occurrences all number
    29

    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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