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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2004-002914-12
    Sponsor's Protocol Code Number:0018
    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:2006-03-28
    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 number2004-002914-12
    A.3Full title of the trial
    A phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Televancin Versus Vancomycin for Treatment of Complicated Gram-positive Skin and Skin Structure Infections with a focus on Patients with infections Due to Methicillin-resistant Staphylococcus aureus
    A.4.1Sponsor's protocol code number0018
    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 SponsorTheravance Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 nameTelavancin
    D.3.2Product code TD-6425 Hydrochloride
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNTelavancin
    D.3.9.1CAS number 380636-75-9
    D.3.9.2Current sponsor codeTD-6424
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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) Information not present in EudraCT
    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 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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 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 Information not present in EudraCT
    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 nameVancomycin
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNVancomycin
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 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 placeboIntravenous infusion
    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
    Complicated Gram-Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-Resistant Staphylococcus aureus.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10040872
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy and safety of Telavancin to Vancomycin in the treatment of adults with Complicated Gram-Positive Skin and Skin Structure Infections with an emphasis on patients with infections due to MRSA.
    E.2.2Secondary objectives of the trial
    To pool the data from this study with those from a second study of identical design (protocol 0017) and to assess the superiority of Telavancin to Vancomycin in patients with MRSA.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Males and Females greater than or equal to 18 years of age
    2) Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA either suspected or confirmed as the major cause of the infection:
    -major abscess requiring surgical incision and drainage
    -infected burn
    -deep/extensive cellulitis
    -infected ulcer
    -wound infections
    3) Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
    4) The following symptoms/signs must be present at the time of enrollment:
    Purulent drainage or collection, OR at least 3 of the following:
    -erythema
    -fluctuance
    -heat and/or localised warmth
    -pain and/or tenderness to palpation
    -swelling and/or induration
    -fever (as defined as >38oC/100.4oF orally, rectally or tympanically)
    -WBC count > 10,000/mm3
    ->15% immature neutrophils (bands) irrespective of WBC count
    5) Accessible site for culture
    6) Informed consent can be obtained for participation in this study as defined by the local Institutional Review Board or Ethics Committee
    E.4Principal exclusion criteria
    1) a. Received more than 24 hrs of potentially effective systemic (IV/IM or PO) antibiotic therapy prior to randomisation, unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days),
    and/or
    b. Requires a non-study systemic (IV/IM or PO) antibacterial regimen to which the target pathogen is susceptible.
    2) Requirement for concomitant administration of agents containing a cyclodextrin solubilizer such as intravenous Sporanox® (itraconazole) or Vfend® (voriconazole).
    3) Patients with baseline QTc >500 msec, congenital long QT syndrome, uncompensated heart failure, uncorrected abnormal K+ or Mg++ blood levels or severe left ventricular hypertrophy.
    4) Uncomplicated skin and superficial skin structure infection (e.g. simple abscess, impetiginous lesion, furuncle or superficial cellulitis).
    5) Self-limited infection (e.g. isolated folliculitis or other infection that has a high surgical incision cure rate, or furunculosis or carbunculosis that is not associated with a cellulitis at least 2cm in radius).
    6) Superinfected eczema, hidradenitis suppurativa or other chronic medical conditions (e.g. atopic dermatitis) where inflammation may be prominent for an extended period even after successful bacterial eradication.
    7) Concurrent infections of unremovable prosthetic materials (e.g. permanent cardiac pacemaker battery packs, or joint replacement prosthesis).
    8) Concurrent presence of osteomyelitis, endocarditis or other deep site tissue infection other than skin and skin structure infection.
    9) Infections due to Gram-positive organism known to be resistant to vancomycin (e.g. vancomycin-resistant enterococcus) or Gram-negative organisms known to be resistant to aztreonam.
    10) Burns involving >20% of body surface area or third degree/full-thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotising fasciitis, gas gangrene, or mediastinitis.
    11) Severely neutropenic (absolute neutrophil count < 500 cells/mm3) or anticipated to develop severe neutropenia during the study treatment period due to prior or planned chemotherapy or have HIV with known CD4 count < 100 cells/mm3 during the last 6 months.
    12) Known hypersensitivity to or intolerance of study medications or their formulation excipients.
    13) a. Female patients of childbearing potential if they are pregnant, nursing or unable to use a highly effective method of birth control during the study and for at least one month following the last dose of study medication. A negative serum pregnancy test must be documented prior to treatment. A highly effective method of birth control is defined as one that results in a low failure rate (i.e. < 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUD's, sexual abstinence, or a vasectomised partner.
    b. Male patients must agree to use medically acceptable birth control for at least three months following last dose of study medication. A vasectomy or a condom used with a spermicide is a medically acceptable birth control method for males.
    14) Prior enrollment in a clinical trial of telavancin.
    15) Treatment with another investigational medication/device within 30 days of study entry.
    16) Patients in shock or who are unlikely to survive through the treatment and evaluation period.
    17) Patients unable to comply with the study procedures.
    18) Any other condition which, in the opinion of an investigator, would confound or interfere with evaluation of safety or efficacy of the investigational drug, or prevent compliance with the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint is the clinical response determined by the investigator at the Test-of-Cure assessment. For purpose of analysis, assessments of "not cured" at End-of-Therapy will be carried forward to Test-of-Cure.

    Secondary Efficacy endpoints are:
    -By-pathogen microbiologic response at Test-of-Cure for MRSA, determined from cultures of the primary infection site. Response will be categorised as "eradicated" or "not eradicated".
    -By-patient microbiologic response at Test-of-Cure, categorised as "eradicated" or "not eradicated".
    -Overall therapeutic response at Test-of-Cure, scored as "overall cure" or "failure" according to the patient's combination of clinical response and by-patient microbiologic response.

    Tertiary Efficacy endpoints are:
    -Clinical response at End-of-Therapy
    -By-pathogen microbiologic response at End-of-Therapy, and Test-of-Cure for each Gram-positive baseline pathogen (other than MRSA at Test-of-Cure)
    -By-patient microbiologic response at End-of-Therapy
    -Duration of treatment with study medication
    -Time to resolution of fever, defined as the first day of the earliest 2-day period during which all temperatures were less than or equal to 38oC
    -Total signs and symptoms score on days 2-7, at End-of-Therapy, and at Test-of-Cure. The assessments of erythema, flactuance, localised warmth, pain/tenderness and edema/induration will each be scored as 0 (absent) or 1 (present). Wound drainage will be scored as 0 (absent), 1 (non-purulent) or 2 (purulent). Total score will be calculated as the sum of the individual scores and thus can range from 0-7.
    -Size of primary infection site, defined as the product of length and width on days 2-7 at End-of-Therapy and at Test-of-Cure

    Safety endpoints are:
    -Adverse events
    -QT and QTc intervals
    -Laboratory results: hematology (hematocrit, hemoglobin, WBC count including differential count by microscopy with % immature neutrophils (bands), mature neutrophils, and eosinophils and platelet count), Serum Chemistry (potassium, magnesium, blood urea nitrogen (BUN), creatinine, total bilirubin, alkaline phosphatase, LDH, ALT (SPGT), AST (SGOT)) and Urinalysis (presence of blood, bilirubin, urobilinogen, nitrate, leukocytes, microscopic examination of sediment (if dipstick positive) and microalbumin).

    Other endpoints are:
    -Development of resistance to study medication
    -Pharmacokinetic parameters
    -Direct medical costs and antibiotic-related length of stay
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 the last visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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.1.3Elderly (>=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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-03-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 1200
    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)
    standard care
    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 Decision2005-04-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-06-15
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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
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