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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   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).

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    Summary
    EudraCT Number:2011-002962-19
    Sponsor's Protocol Code Number:SKA 001
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-07
    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 ConcernedIreland - HPRA
    A.2EudraCT number2011-002962-19
    A.3Full title of the trial
    CHLORHEXIDINE VERSUS POVIDONE-IODINE FOR SKIN ANITSEPSIS PRIOR TO CENTRAL VENOUS CATHETER INSERTION IN PRETERM INFANTS: PROTOCOL FOR A RANDOMISED TRIAL (THE SKA TRIAL)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare the ability of two antispetic agents (Chlorohexidine and Povidone-iodine), when applied to the skin prior to insertion of a tube into a premature infant, to prevent infections in the blood stream.
    A.3.2Name or abbreviated title of the trial where available
    THE SKA TRIAL
    A.4.1Sponsor's protocol code numberSKA 001
    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 College Dublin
    B.1.3.4CountryIreland
    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 supportNational Children’s Research Centre at Our Lady’s Children’s Hospital, Crumlin
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJava Clinical Research
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFitzwilliam Business Centre, 26/27 Upper Pembroke Street
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code2
    B.5.3.4CountryIreland
    B.5.4Telephone number353016373903
    B.5.5Fax number353016373907
    B.5.6E-mailinfo@javacr.com
    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 ChloraPrep® 2% w/v / 70% v/v cutaneous solution
    D.2.1.1.2Name of the Marketing Authorisation holderInsight Health Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameChloraPrep® 2% w/v / 70% v/v cutaneous solution
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNChlorhexidine gluconate 2.0% w/v in Isopropyl alcohol 70% v/v
    D.3.9.1CAS number 18472-51-0
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2%
    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.IMP: 2
    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 Videne 10% w/w Antiseptic Solution
    D.2.1.1.2Name of the Marketing Authorisation holderEcolab Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameVidene 10% w/w Antiseptic Solution
    D.3.4Pharmaceutical form Cutaneous solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIodinated povidone 10% w/w
    D.3.9.1CAS number 25655-41-8
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Blood stream infections in neonates
    E.1.1.1Medical condition in easily understood language
    Infections in the blood in newborn infants
    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 the use of 2% chlorhexidine in 70% isopropyl alcohol compared to 10% povidone-iodine for skin antisepsis prior to central venous catheter insertion results in fewer catheter related blood stream infections in infants<31 weeks gestation
    E.2.2Secondary objectives of the trial
    To determine whether using chlorhexidine compared to povidone-iodine for skin antisepsis before central line insertion in preterm infants is associated with beneficial effects (e.g. shorter hospital stay) or negative effects (e.g. increased skin reactions).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    Only infants who meet all of the following inclusion criteria will be eligible for enrolment into this study:
    1. Born at < 31 weeks gestation (by best obstetric estimate)
    2. Have a central venous catheter inserted (UVC or PICC) in the neonatal intensive care unit (NICU) of one of the participating centres.
    3. Who’s parent/legal guardian are willing and able to understand and provide written, informed consent prior to their Infant’s participation in the study.
    E.4Principal exclusion criteria
    Infants meeting any of the following exclusion criteria are not eligible for enrolment into this study:

    1. Infants with major congenital anomalies, including but not limited to gastroschisis, diaphragmatic hernia, oesophageal atresia, omphalocoele; tracheo-oesophageal fistula; neural tube defect; structural heart lesion other than patent ductus arteriosus or small atrial or ventricular septal defect.
    2. Infants who have previously had a CVC placed at a participating or referring hospital.
    3. Infants who are participating in another clinical trial involving an investigational medicinal product.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint
    The primary endpoint for this study is the number of infants with a Catheter Related Blood Stream Infections (CR-BSI). Infants will be diagnosed with a CR-BSI if they have:

    1. CVC (UVC or PICC) in situ or removed within previous 48 hours
    AND
    o a recognized pathogen (e.g staphylococcus aureus, candida) on 1 peripheral blood culture (i.e. not taken through CVC) not related to an infection at another site
    OR
    o a common skin commensal (e.g. CONS) cultured from 2 or more peripheral blood cultures drawn on separate occasions
    OR
    o a common skin commensal (e.g. CONS) isolated from 1 peripheral blood culture with a CVC tip culture growing > 15 colonies of a pure growth of the same
    E.5.1.1Timepoint(s) of evaluation of this end point
    The decision to perform a blood culture will be at the discretion of the treating clinicians. The primary outcome will be determined by one Investigator from blood culture results and CVC tip culture results. This Investigator will be masked to the infant’s treatment allocation.
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are assessment of the following parameters in relation to catheter related blood stream infections:
    o Number of CVC insertions, attempted and successful
    o Duration CVC in situ (days)
    o Number of blood cultures taken
    o Episodes of positive blood culture and ≥ 5 days of antibiotics
    o Number of courses of antibiotics
    o Duration of antibiotic therapy (days)
    o Skin reactions to cleansing solutions
    o Number of CSF confirmed infections
    o Pericardial effusions
    o Pleural effusions
    o Bacterial endocarditis
    o Raised thyroid stimulating hormone levels on newborn screening (Guthrie) card
    o Duration of mechanical ventilation (days)
    o Duration of CPAP (days)
    o Duration of oxygen therapy (days)
    o Oxygen therapy at 28 days of age
    o Oxygen therapy 36 weeks’ post-menstrual age
    o Home oxygen therapy required upon discharge
    o Air leaks
    o Medical and surgical treatment for patent ductus arteriosus
    o Duration receiving parenteral nutrition (days)
    o Time to 120mL/kg/day enteral feeds
    o Gastrointestinal perforation
    o Necrotising enterocolitis
    o Cranial ultrasound abnormalities (intraventricular hemorrhage and periventricular leukomalacia)
    o Retinopathy of prematurity
    o Duration of hospital stay (days)
    o Death before discharge
    E.5.2.1Timepoint(s) of evaluation of this end point
    These secondary endpoints will be assessed from time of insertion of first CVC until death or discharge.
    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 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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    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
    The end of the trial is defined as the last visit of the last subject undergoing the trial.
    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 months4
    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 Yes
    F.1.1Number of subjects for this age range: 304
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 304
    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) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    This study will enroll neonates. The consent will be given by parent or legal guardian.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state304
    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)
    After the subject has ended their participation in the trial, they will be treated as per standard medical care for this patient population.
    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 Decision2011-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-19
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