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    Summary
    EudraCT Number:2009-015744-42
    Sponsor's Protocol Code Number:NA
    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:2009-09-11
    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 number2009-015744-42
    A.3Full title of the trial
    Randomized open label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: Preliminary study in a single centre.
    A.3.2Name or abbreviated title of the trial where available
    Oral versus intravenous antibiotics for bone and joint infection
    A.4.1Sponsor's protocol code numberNA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOxford Radcliffe Hospitals 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    Oral 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) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Bone and joint infection including;
    o Osteomyelitis.
    o Septic arthritis.
    o Prosthetic joint associated infection
    o Orthopaedic device associated infection
    o Discitis/ epidural abscess
    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
    We will compare the frequency of treatment failure with oral versus intravenous antibiotic treatment in two centres supported by a single clinical infection service. This will be needed to exclude a very marked worsening of outcome in patients on oral antibiotics. These data will be needed to justify a larger multi-centre study.
    E.2.2Secondary objectives of the trial
    To measure the nature, frequency and intensity of adverse events resulting from oral versus intravenous antibiotics.
    To identify the development of antibiotic resistance while on therapy or during the follow-up period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Is willing and able to give informed consent for participation in the study.
    • Has a bone and joint infection* in one of the following categories;
    1. Native osteomyelitis (i.e., bone infection without metalwork) where a prolonged (i.e., 6 week) course of antibiotics is indicated (i.e., excluding limited superficial disease, or patients where curative amputations or excisions of all infected bone have been carried out).
    2. Native joint septic arthritis treated by excision arthoplasty, with or without intended 2-stage revision.
    3. Diabetic foot infection with proven or presumptive osteomyelitis where a prolonged (i.e. 6 week) course of antibiotics is indicated (i.e., excluding limited superficial disease or patients where curative excision of all infected bone has been carried out).
    4. Prosthetic joint associated infection treated by debridement and retention
    5. Orthopaedic device associated infection treated by debridement and retention
    6. Prosthetic joint associated infection where a 2 stage revision is planned, randomizing the patient after the 1st stage (i.e., after excision of the infected prosthesis).
    7. Prosthetic joint associated infection treated by 1 stage revision
    8. Removal of orthopaedic device or bone graft for infection (excluding limited superficial disease requiring short courses of antibiotics).
    9. Discitis/ spinal osteomyelitis/ epidural abscess
    • Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already given after definitive surgical management*.
    • Has a clinical diagnosis of bacterial infection (caused by any organism excepting mycobacteria).
    • Has a life expectancy > 1 year.
    • Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.
    E.4Principal exclusion criteria
    • Has Staph aureus bacteraemia found on blood cultures taken for clinical indications. (No study-required blood cultures will be taken). Patients with Staph aureus bacteraemia often require longer courses of intravenous antibiotics, and may be the subject of a separate randomized trial.
    • Has suspected bacterial endocarditis, based on clinical, microbiological or imaging studies. (No study-required echocardiograms will be requested). Patients with endocarditis are considered to need longer courses of intravenous antibiotics.
    • Has suspected mediastinial infection
    • Has suspected central nervous system infection
    • Is unlikely to comply with trial requirements in the opinion of the investigator.
    • Has an infection for which there is no suitable antibiotic choices to permit randomization between the two arms of the trial
    • Has a non-bacterial (i.e., mycobacterial, fungal, parasitic or viral) infection based on clinical, histological or microbiological findings at site of infection.
    • Previously enrolled in the trial.
    • Is receiving an investigational medical product as part of another clinical trial.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be definite failure of infection treatment, where definite failure is indicated by one or more of the following;
    1. Significant positive culture results from invasive specimens taken from the infected site, where cultures where taken for evidence of worsening infection (i.e. not taken as a matter of routine at planned surgery).
    2. A positive culture result from a blood specimen taken in association with clinical signs of recurrent infection at the primary site of treatment, and where there is no other likely source of the positive blood culture (e.g., line infection, pneumonia).
    3. An operative appearance of the infected site diagnostic of active infection at the time of unplanned surgery (e.g., frank pus or necrotic tissue)
    4. A sinus tract at the infected site ≥3 weeks after surgical intervention.
    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) Information not present in EudraCT
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    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.8.3 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 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 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 last visit of the last subject.
    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
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Intravenous therapy is currently available in Oxford to patients requiring it. If demonstrated that oral therapy was equivalence, no further infrastructure is required to change policy.
    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 Decision2009-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-11
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    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.

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