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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2011-004745-40
    Sponsor's Protocol Code Number:n/a
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-004745-40
    A.3Full title of the trial
    Studies of the effects of a one week course of either azithromycin or metronidazole on plasma concentration of procalcitonin in patients with heart failure and elevated plasma procalcitonin concentrations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of antibiotic use and its effects on a marker of infection in chronic heart failure
    A.3.2Name or abbreviated title of the trial where available
    PROCALCITONIN-HF v2.0 24th_January_2012
    A.4.1Sponsor's protocol code numbern/a
    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 SponsorHull and East Yorkshire Hospitals NHS Trust.
    B.1.3.4CountryUnited Kingdom
    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 supportBrahms Thermofisher
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Hull
    B.5.2Functional name of contact pointJames Hobkirk
    B.5.3 Address:
    B.5.3.1Street AddressDaisy Building, CHH, Castle Road
    B.5.3.2Town/ cityCottingham
    B.5.3.3Post codeHU16 5JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482 461796
    B.5.5Fax number01482 461808
    B.5.6E-mailJames.hobkirk@hey.nhs.uk
    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 Azithromycin
    D.2.1.1.2Name of the Marketing Authorisation holderTechnPharm Ltd
    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 nameAzithromycin
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Tablet
    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 INNAzithromycin
    D.3.9.1CAS number 83905-01-5
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 500
    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 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 Actavis
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Ltd
    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 nameMetronidazole
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Tablet
    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 INNMetronidazole
    D.3.9.1CAS number 443-48-1
    D.3.9.2Current sponsor coden/a
    D.3.9.3Other descriptive namen/a
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic heart failure.
    E.1.1.1Medical condition in easily understood language
    The heart has a reduced ability to supply the body with sufficient blood to perform optimally.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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
    In patients with heart failure who have an elevated concentration of procalcitonin (a marker of infection) which is not explained by clinical evidence of infection, can treatment for one week with azithromycin or with metronidazole reduce plasma concentrations of procalcitonin compared to a control group who receive no antibiotics. Procalcitonin is associated with a poor prognosis so understanding the mechanism for an elevated concentration in those without infection may provide a therapeutic target.
    E.2.2Secondary objectives of the trial
    Secondary endpoints are :
    Change in procalcitonin between baseline and two weeks
    change in procalcitonin between baseline and six weeks
    change in procalcitonin between one and two weeks
    change in procalcitonin between one and six weeks
    change in cardiovascular measurements at one, two and six week; time course of any cardiovascular changes and their relationship to changes in procalcitonin

    In addition, we will evaluate the patients’ haemodynamic profiles in detail using painless, non-invasive technologies including measure of pulse wave velocity and characteristics (ENVERDIS), bio-impedance (NICAS), photo-plethysmography (NEXFIN) and Echocardiography. We will also measure a range of cardiovascular risk markers including(NT-proBNP, Galectin-3), inflammatory (hsCRP, PCT, acylation stimulatory protein, lipopolysaccharides and renal (NGAL) biomarkers in plasma, serum or urine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ability to give, legally valid, written informed consent
    • Clinical diagnosis of heart failure
    • NT-proBNP plasma concentration >400ng/L
    • Procalcitonin plasma concentration >50 pg/ml
    E.4Principal exclusion criteria
    • Age <18 years
    • Inability to understand or read English.
    • Women of child bearing potential
    • Antibiotic use in the prior 6 weeks
    • Endocarditis
    • Any known cancer
    • Previous major adverse effect to azithromycin or metronidazole (eg:- allergy, severe diarrhoea, need for hospital treatment of adverse effect)
    • Unwilling to avoid alcohol for one week (requested in all arms of the study)
    • Surgery of any kind in previous 6 weeks (includes device implantation)
    • Heart transplant recipient
    • Recipient of a left ventricular assist device
    • Inability to follow instructions or comply with follow-up procedures
    • Porphyria (use of macrolides and metronidazole is contra indicated )
    • Contra-indications to one week’s treatment with azithromycin, metronidazole (if not already listed in the exclusion criteria)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is change in procalcitonin from baseline to the evaluation at 7-days in patients who either receive an antibiotic compared to those that do not. We intend to compare

    a) Both antibiotic arms grouped together to no antibiotic therapy
    b) Azithromycin to no therapy
    c) Metronidazole to no therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    We measure procalcitonin concentrations at baseline (i.e. before the treatment is taken (or not, in the case of the control group)), after one week of treatment and then after two and six weeks of follow-up.
    E.5.2Secondary end point(s)
    • Change in procalcitonin between
    o baseline and two weeks
    o baseline and six weeks
    o one and two weeks
    o one and six weeks

    • Changes in hsCRP, NT-proBNP, serum urea and creatinine, systolic blood pressure, systemic vascular resistance, augmentation index at one, two and six weeks.
    • Relationships between changes in procalcitonin and changes in hsCRP, NT-proBNP, serum urea and creatinine, acyaltion stimulatory protein, lipopolysaccaharides, systolic blood pressure, systemic vascular resistance, global augmentation index at one, two and six weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Same as primary end-points
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard therapy for heart failure
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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 study will be complete 5 weeks after the 60th patient has completed one week of follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    All patients would be treated to according to optimal clinical guidelines
    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 Decision2012-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-30
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