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    The EU Clinical Trials Register currently displays   35513   clinical trials with a EudraCT protocol, of which   5839   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-002106-31
    Sponsor's Protocol Code Number:44512
    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:2014-01-16
    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 number2013-002106-31
    A.3Full title of the trial
    The DANCE study: Duration of ANtibiotic therapy for CEllulitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotics for cellulitis: 6 or 12 days?
    Antibiotica voor cellulitis: 6 of 12 dagen?
    A.3.2Name or abbreviated title of the trial where available
    DANCE
    A.4.1Sponsor's protocol code number44512
    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 SponsorAcademic Medical Center
    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 supportNetherlands Organisation for Health Research and Development (ZonMw)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointhead investigator
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9, room G2-132
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31205669111
    B.5.6E-mailw.j.wiersinga@amc.uva.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 Yes
    D.2.1.1.1Trade name Flucloxacillin
    D.2.1.1.2Name of the Marketing Authorisation holderApotex Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameFlucloxacillin
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    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
    Cellulitis
    (Cellulitis is a common acute, spreading pyogenic inflammation of the skin (dermis) and subcutaneous tissue, usually complicating a wound, ulcer or dermatosis)
    Bacteriele huidinfecties
    E.1.1.1Medical condition in easily understood language
    Skin infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    To determine whether 6 days of flucloxacillin has equal efficacy compared to 12 days in patients hospitalized with cellulitis who after 5 days of initial therapy have substantially improved, defined as absence of fever (temp > 38.0°C) and improvement in cellulitis severity score (self-reported or investigator assessed).
    E.2.2Secondary objectives of the trial
    - To assess differences in the frequency of relapse by day 90
    - To assess differences in (A) speed of improvement of symptoms and (B) quality of life
    - To assess the effects of 6 days of antibiotics compared to 12 days on total antibiotic use and health care costs
    - To analyse inflammation parameters in the (epi)dermis and blood during cellulitis, to explore markers of disease severity and determinants of therapeutic failure
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria. Subjects must be:
    - Admitted to the hospital to receive intravenous antibiotics for cellulitis/erysipelas. Cellulitis is the general the general descriptive term suggesting infection and indicating the warmth, erythema and induration of skin and/or subcutaneous tissue, with or without pain (this also includes erysipelas, see appendix I).
    - 18 years of age or older
    - Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
    E.4Principal exclusion criteria
    As this study focuses on the treatment of cellulitis requiring hospitalization without additional complicating factors, a potential subject who meets any of the following criteria will be excluded from participation:
    - Allergy for flucloxacillin, other beta-lactam antibiotics or one of the additives, or flucloxacillin induced hepatitis or liver enzyme disorders
    - Concurrent use of antibiotics for other indications
    - Alternative diagnosis accounting for the clinical presentation.
    - All cases involving any of the following complicating factors:
    o Use of antibiotics with Gram-positive activity for more than 4 days in the past 7 days
    o Intensive care unit admission during the last 7 days
    o Risk factors associated with Gram-negative pathogens as a causative agent19:
    o Chronic or macerated infra-malleolar ulcers, or infra-malleolar ulcers with previous antibiotic treatment, in patients with diabetes mellitus 20
    o Neutropenia
    o Cirrhosis (Child-Pugh class B or C)
    o Intravenous drug use
    o Human or animal bite
    o Skin laceration acquired in fresh or salt open water
    o Fish fin or bone injuries
    o Severe peripheral arterial disease (Fontaine IV)
    o Severe cellulitis necessitating surgical debridement or fascial biopsy
    o Necrotizing fasciitis
    o Periorbital or perirectal involvement
    o Surgery
    o Life expectancy less than one month
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is resolution of cellulitis at 14 days, defined as disappearance of warmth and tenderness at the site of infection, with substantial improvement in erythema and edema, and without recurrence by day 28, defined as the need of additional antibiotic therapy for cellulitis.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14, 28.
    E.5.2Secondary end point(s)
    • Recurrence of cellulitis by day 90 after inclusion, defined as the need of additional antibiotic therapy for cellulitis
    • Speed of recovery, as determined by improvement in cellulitis severity score, and self assessment of subjective pain and swelling on Visual Analog Scales scales (0-10), assessed at baseline (day 0), days 2-3, 5-6, 14, 28 and 90 (day 90 self-assessment only)12
    • Mean health-related Quality of Life (using the Dutch SF-36 questionnaire and the EQ-5D) at day 0, 28 and 90.
    • Health care resource utilisation, as determined by total antibiotic use and effect on direct and indirect health-care associated costs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, 2-3, 5-6, 14, 28, 90.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) 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 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 concerned8
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 316
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 316
    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 No
    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 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 state316
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Academic Medical Center
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation VUmc
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Sint Lucas Andreas Ziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Flevoziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation OLVG
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Slotervaart ziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation UMCU
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Diakonessenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Tergooi ziekenhuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation Kennemer Gasthuis
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation St. Antonius Ziekenhuis
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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