Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-002068-29
    Sponsor's Protocol Code Number:1-09-09-2012
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-13
    Trial results View 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 ConcernedDenmark - DHMA
    A.2EudraCT number2012-002068-29
    A.3Full title of the trial
    Antibiotic Prophylaxis and Intervention for Postpartum Infections following Caesarean Section
    Forebyggelse af og intervention ved postoperative infektioner efter sectio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pervention and Intervention of infections following Caesarean Section
    Forebyggelse og behandling af infektoner efter kejsersnit
    A.3.2Name or abbreviated title of the trial where available
    The APIPICS study
    A.4.1Sponsor's protocol code number1-09-09-2012
    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 SponsorJan Stener Joergensen
    B.1.3.4CountryDenmark
    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 supportUniversity of Southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion of Southern Denmark
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointNana Hyldig
    B.5.3 Address:
    B.5.3.1Street AddressKloevervaenget 10, 10. floor
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number004564415156
    B.5.6E-mailnana.hyldig@ouh.regionsyddanmark.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Cefuroxim
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Intravesical solution/solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEFUROXIME SODIUM
    D.3.9.1CAS number 56238-63-2
    D.3.9.4EV Substance CodeSUB01140MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sub-study 1: women delivering a child by caesarean section

    Sub-study 2: Women, who are hospitalized at the obstetrical ward for reoperation because of superficial or deep infection or haematoma after caesarean section
    E.1.1.1Medical condition in easily understood language
    Sub-study 1: women delivering a child by caesarean section

    Sub-study 2: Women, who are hospitalizedfor reoperation because of infection or haematoma after caesarean section
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Sub-study 1: Whether and by how much iv Cefuroxim 1,5g administered 15-60 minutes before incision versus after umbilical cord clamping reduces the rate of postpartum infection in a Danish population of women undergoing caesarean section

    Sub-study 2: Whether NPWT is effective compared to conventional wound treatment in the period of time from reoperation to re-suturing in women having surgical wound rupture after caesarean section, assessed by the frequency of re-rupture, the cosmetic outcome and a quality of life measurement?
    E.2.2Secondary objectives of the trial
    The health economic cost and consequences of prophylaxis of and intervention for infections post-CS.

    a) Are antibiotics administered before incision cost-effective, compared to administration after umbilical cord clamping, measured by post-caesarean section
    infection and as cost per Quality Adjusted Life Year (QALY)?

    b) Is NPWT cost-effective, compared to conventional treatment, measured as cost per QALY gained?

    c) Do women treated with NPWT experience a greater HRQoL than women receiving conventional treatment?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sub-study 1:
    - Age ≥ 18 year
    - Women, who can read and understand Danish
    - A gestational age ≥ completed 28 weeks of gestation
    - Rupture of membranes and active labour (uterine contractions) is allowed

    Sub-study 2:
    - Age ≥ 18 year
    - Women, who can read and understand Danish
    E.4Principal exclusion criteria
    Sub-study 1:
    - Hypersensitivity to cefuroxim or to any other cephalosporin antibiotics
    - Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
    - Systemic exposure to any antibiotic agent within 1 week before delivery Antibiotic indicated due to PROM, fever, GBS or other indications at the time of caesarean section.
    - Women being immunologically incompetent (e.g. HIV positive)

    Sub-study 2:
    - Serious illness requiring medical treatment, such as cancer
    - Stillborn child
    - If the fascia is ruptured
    E.5 End points
    E.5.1Primary end point(s)
    Sub-study 1:
    Maternal: The incidence of post-caesarean section infection (endometritis, UTI and WI) in each study group.
    Infant: Admission to special care unit

    Sub-study 2: The frequency of re-rupture in each study group
    E.5.1.1Timepoint(s) of evaluation of this end point
    Sub-study 1: Estimated 30 days post-caesarean section (To be able to collect information about symptoms of infection after discharge the paticipant need to fill out a self-administered questionnaire. The questionnaire will be sent to all participants within 30 days post-caesarean section).


    Sub-study 2: Approximately 6 months after the reoperation
    E.5.2Secondary end point(s)
    Sub-study 1:
    Maternal: Length of the primary and any secondary hospitalization, readmissions to hospital/contact to the general practitioner on suspicion of infection after caesarean section and antibiotic treatment
    Infant: Use of antifungal treatment against oral thrush, NEC (necrotizing enterocolitis), antibiotic treatment during hospital stay, the need for intensive care treatment and length of stay in hospital. Long-term adverse effects will be evaluated three years after CS (not part of the PhD), including frequency of visits to hospital, and use of antibiotics, asthma inhalation medicine, and systemic and topical steroids).

    Sub-study 2: The cosmetic outcome and the HRQoL, measured in QALYs at the two interventions, wound healing rate in percent from the dehiscence/opening of the surgical wound to re-suturing, measured at the 0th, 2nd and 4th day, and the time to 100% wound healing.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Sub-study 1: Approximately 30 days after LPLV. Microbiological analyzes and data processing is expected to be completed one year after the LPLV


    Sub-study 2: LPLV
    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 Yes
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    A Health Economic Assessment
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    A quality assurance trial of two methods of wound treatment
    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 concerned3
    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 No
    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
    Sup-study 1: Estimated 30 days after LPLV (To be able to collect information about symptoms of infection after discharge the paticipant need to fill out a self-administered questionnaire. The questionnaire will be sent to all participants within 30 days post-caesarean section).

    Sub-study 2: LPLV

    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 months
    E.8.9.1In the Member State concerned days
    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: 2844
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state2844
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 2844
    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)
    None - unless a woman is hospitalized because of superficial or deep infection or haematoma after caesarean section. Then she is a candidate for the sub-study 2.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-23
    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.

    European Medicines Agency © 1995-Thu May 02 08:36:27 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA