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    The EU Clinical Trials Register currently displays   37235   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005736-17
    Sponsor's Protocol Code Number:NL56697.041.16
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-06-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-005736-17
    A.3Full title of the trial
    Prevention of severe infectious complications after colorectal surgery using antimicrobial decontamination of the digestive tract (PreCaution trial)
    Het voorkomen van ernstige infectieuze complicaties na colorectale chirurgische ingrepen middels preoperatieve orale antibiotische decontaminatie van het maagdarmkanaal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of wound infections after colorectal surgery using antibiotics prior to surgery
    Het voorkomen van wond infecties na dikke darm operaties door middel van antibiotica voorafgaand aan de operatie
    A.3.2Name or abbreviated title of the trial where available
    PreCaution
    A.4.1Sponsor's protocol code numberNL56697.041.16
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointDrs. Tessa Mulder
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CX Utrecht
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031887568190
    B.5.6E-mailt.mulder-2@umcutrecht.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSDD voor darmchirurgie
    D.3.2Product code 16059670
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLISTIN SULFATE
    D.3.9.1CAS number 1264-72-8
    D.3.9.4EV Substance CodeSUB01431MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTobramycinum
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number16
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition under investigation: surgical site infections (bacterial) after elective colorectal surgery.

    De medische conditie die wordt onderzocht gedurende deze studie: postoperatieve wondinfecties (bacterieel), ontstaan na electieve colorectale operaties.
    E.1.1.1Medical condition in easily understood language
    Wound infections after colorectal surgery
    Wondinfecties na operatie aan de dikke darm
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053562
    E.1.2Term Surgical wound infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10056641
    E.1.2Term Post procedural site wound infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10074392
    E.1.2Term Deep postoperative wound infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10074393
    E.1.2Term Superficial postoperative wound infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the effect of preoperative oral antibiotic prophylaxis (Pre-OP), in addition to standard perioperative intravenous antimicrobial prophylaxis, in patients undergoing elective colorectal surgery, on the cumulative incidence of deep SSI and/or mortality within 30 days after colorectal surgery.
    De primaire doelstelling van de studie is het bepalen van het effect van preoperative orale antibiotische profylaxe (Pre-OP) in aanvulling op de standaard perioperatieve intraveneuze antibiotische profylaxe bij patiënten die electieve colorectale operaties ondergaan op de cumulatieve incidentie van diepe postoperatieve wondinfecties en/of mortaliteit binnen 30 dagen na de operatie
    E.2.2Secondary objectives of the trial
    1. To determine the effect of Pre-OP, in addition to standard perioperative intravenous antibiotic prophylaxis, in patients undergoing elective colorectal surgery on:
    a) The cumulative incidence of superficial incisional SSI within
    b) The cumulative incidence of anastomotic leakage (AL)
    c) The all-cause mortality
    d) The cumulative incidence of relaparotomy
    e) The cumulative incidence of bacteraemia
    f) The cumulative incidence of infections
    i. Highly-resistant micro-organisms (HRMO)
    ii. Clostridium difficile
    g) The postoperative length of hospital stay, including readmissions
    h) The postoperative length of ICU stay, including readmissions
    i) The in-hospital costs
    j) The in-hospital use of antibiotics
    k) The quality of life

    2. To identify risk factors for SSI and assess whether these are dependent on:
    a) The type of surgery (e.g. colon versus rectum)
    b) The use of Pre-OP (active study medication versus placebo)
    1. Het bepalen van het effect van Pre-OP, als aanvulling op de standaard perioperatieve intraveneuze antibiotische profylaxe bij patienten die electieve colorectale operaties ondergaan op:
    a) de cumulatieve incidentie van oppervlakkige postoperatieve wondinfecties
    b) de cumulatieve incidentie van naadlekkages
    c) mortaliteit
    d) de cumulatieve incidentie van relaparatomiën
    e) de cumulatieve incidentie van bacteriemieen
    f) de cumulatieve incidentie van infecties
    i) multiresistente micro-organismen
    ii) Clostridium difficile
    g) de postoperatieve opnameduur, inclusief heropname
    h) de postoperatieve opnameduur op de intensive care, inclusief heropname op de intensive care
    i) Zorgkosten
    j) Gebruik van antibiotica gedurende de opname
    k) Quality of life

    2. Het vaststellen van risicofactoren voor het ontwikkelen van postoperatieve wondinfecties en onderzoeken of deze afhankelijk zijn van:
    a) het type operatie
    b) het toepassen van Pre-OP
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (18 years of age or older) undergoing elective colorectal surgery. Elective surgery is defined as surgery for which there is no need to be performed immediately, with the possibility to be scheduled at the patient’s and surgeon’s convenience
    - Abovementioned patients may not meet any of the exclusion criteria
    - Volwassen patiënten (18 jaar of ouder) die een colorectale operatie ondergaan. Onder electief wordt verstaan: operatieve ingrepen die niet direct uitgevoerd en planbaar zijn
    - Op de bovengenoemde patiënten mogen geen van de exclusie criteria van toepassing zijn
    E.4Principal exclusion criteria
    Patients who meet one or more of the following criteria will not be eligible to participate in this study:

    - Patients aged <18 years
    - Legally incapacitated patients or patients who refuse to sign informed consent.
    - Patients with an inability to take oral medication
    - Patients who have undergone abdominal surgery within 30 days before randomisation
    - Patients who have a known and documented allergy to any of the medications or agents used (i.e. colistin, tobramycin or other aminoglycoside antibiotics)
    - Patients diagnosed with myasthenia gravis
    - Pregnant women and nursing mothers
    - Patients undergoing colorectal surgery in an emergency setting (i.e. not elective)
    - Patients with an ileostomy
    - Patients who already participated in the PreCaution trial
    Patiënten waarbij 1 of meer van de volgende exclusie criteria van toepassing is/zijn komen niet in aanmerking voor deelname aan de studie:

    - Patiënten met een leeftijd onder de 18 jaar
    - Wilsonbekwame patiënten of patiënten die weigeren het informed consent te tekenen
    - Patiënten waarbij de inname van studiemedicatie niet mogelijk is of niet veilig wordt geacht (e.g. slikstoornissen)
    - Patiënten die <30 dagen voor randomisatie een buikoperatie hebben ondergaan
    - Patiënten met een bekende allergie voor colistine, tobramycine of andere aminoglycoside antibiotica
    - Patiënten gediagnosticeerd met myastenia gravis
    - Zwangere vrouwen of vrouwen die borstvoeding geven
    - Patiënten die colorectale operatie ondergaan in een trauma/acute setting (i.e. niet electief)
    - Patiënten met een reeds preoperatief bestaand ileostoma
    - Patienten die al hebben deelgenomen aan de PreCaution studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is a composite endpoint, consisting of: deep surgical site infection and/or mortality
    Het primaire eindpunt is een samengesteld eindpunt bestaande uit: diepe postoperatieve wondinfectie en/of mortaliteit
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after elective surgery
    30 dagen na electieve operatie
    E.5.2Secondary end point(s)
    1. The cumulative incidence of superficial incisional SSI
    2. The cumulative incidence of anastomotic leakage
    3. The all-cause mortality
    4. The cumulative incidence of relaparotomy
    5. The cumulative incidence of bacteraemia
    6. The cumulative incidence of infections with:
    - Highly-resistant Enterobacteriaceae (HRE)
    - Clostridium difficile
    7. The presence of HRE in the intestinal flora
    8. The postoperative length of hospital stay, including readmissions
    9. The postoperative length of ICU stay, including readmissions
    10. The in-hospital use of antibiotics
    11. The in-hospital costs
    12. The quality of life
    1. De cumulatieve incidentie van oppervlakkige postoperatieve wondinfecties
    2. De cumulatieve incidentie van naadlekkage
    3. Mortaliteit (alle oorzaken)
    4. De cumulatieve incidentie van relaparatomie
    5. De cumulatieve incidentie van bacteriemieën
    6. De cumulatieve incidentie van infecties met
    - Multi-resistentie Enterobacteriaceae (HRE)
    - Clostridium difficile
    7. De aanwezigheid van HRE in de intestinale flora
    8. Postoperatieve opname duur, inclusief heropnames
    9. Postoperatieve opnameduur op de Intensive Care, inclusief heropnames
    10. Gebruik van antibiotica gedurende de opname
    11. Zorgkosten
    12. Kwaliteit van leven
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after elective colorectal surgery (endpoint 1,2,4-7,10)
    6 months after elective colorectal surgery (endpoint 3,8,9,11,12)
    30 dagen na electieve colorectale operatie (eindpunt 1,2,4-7,10)
    6 maanden na electieve colorectale operatie (eindpunt 3,8,9,11,12)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is when the 6-month follow-up of the last patient is completed (patient 966)
    Het einde van de trial is wanneer de 6 maanden follow-up van de laatste patiënt is voltooid (patiënt 966)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 483
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 483
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state966
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    There will be no changes to the standard treatment when the subject has ended his or her participation in the trial
    Er zal geen sprake zijn van een veranderde of aangepaste behandeling van de patient wanneer zijn of haar deelname aan de studie is beeindigd
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-08-22
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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