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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   43974   clinical trials with a EudraCT protocol, of which   7312   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2007-000599-18
    Sponsor's Protocol Code Number:P903-09
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-22
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-000599-18
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline versus Ceftriaxone in the Treatment of Adult Subjects with Community-Acquired Pneumonia
    A.4.1Sponsor's protocol code numberP903-09
    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 SponsorCerexa, 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 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.3.1Product nameCeftaroline for Injection (Ceftaroline)
    D.3.2Product code USAN: Ceftaroline acetate
    D.3.4Pharmaceutical form Powder for solution for 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.3.9.1CAS number 866021-48-9
    D.3.9.2Current sponsor codeCeftaroline for Injection
    D.3.9.3Other descriptive nameResearch codes: PPI-0903, TAK-599
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.2.1.1.1Trade name Ceftriaxon Hikma 1g
    D.2.1.1.2Name of the Marketing Authorisation holderHikma Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCeftriaxon Hikma 1g
    D.3.4Pharmaceutical form Powder for solution for 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 INNCeftriaxone
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboSolution for 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
    Adult Subjects with Community-Acquired Pneumonia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the non-inferiority in the overall (clinical and radiographic) success rate for ceftaroline compared to that for ceftriaxone at the Test-of-Cure (TOC) visit in the Clinically Evaluable (CE) and Modified Intent-to-Treat (MITT) populations in adult subjects with community-acquired pneumonia (CAP)
    E.2.2Secondary objectives of the trial
    • Evaluate the clinical response at the End-of-Therapy (EOT) and TOC visits
    • Evaluate the microbiological success rate at the TOC visit
    • Evaluate the clinical and microbiological response by pathogen at the TOC visit
    • Evaluate clinical relapse at the Late Follow-up (LFU) visit
    • Evaluate microbiological re-infection/recurrence at the LFU visit
    • Evaluate safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects are required to meet the following inclusion criteria:

    1. Males and females 18 or more years of age
    2. Community-acquired pneumonia meeting the following criteria:

    I. Radiographically-confirmed pneumonia (new or progressive pulmonary infiltrate(s) on chest radiograph (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia)

    AND

    II. Acute illness (≤7 days’ duration) with at least three of the following clinical signs or symptoms consistent with a lower respiratory tract infection:
    • New or increased cough
    • Purulent sputum or change in sputum character
    • Auscultatory findings consistent with pneumonia (e.g. rales, egophony, findings of consolidation)
    • Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% on room air or pO2 <60 mm Hg)
    • Fever greater than 38ºC oral (>38.5ºC rectally or tympanically) or hypothermia (<35ºC)
    • White blood cell (WBC) count greater than 10,000 cells/mm3 or less than 4,500 cells/mm3
    • Greater than 10% immature neutrophils (bands) irrespective of WBC count

    AND

    III. PORT score greater than 50 and less than or equal to 130 (i.e. PORT Risk Class II, III, or IV)

    3. The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care.
    4. The subject’s infection would, by the standard of care, require initial treatment with IV antimicrobials.
    5. Female subjects of child-bearing potential who are fewer than 2 years post-menopausal must agree to, and comply with, using highly effective methods of birth control (i.e. condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study.
    6. Written informed consent, willingness, and ability to comply with all study procedures.
    E.4Principal exclusion criteria
    Subjects must NOT meet any of the following exclusion criteria:

    1. PORT score less than or equal to 50 (PORT Risk Class I), PORT score greater than 130 (PORT Risk Class V), or requiring admission to an intensive care unit
    2. CAP suitable for outpatient therapy with an oral antimicrobial agent
    3. Respiratory tract infections attributable to sources other than community-acquired bacterial pathogens (e.g. ventilator-associated pneumonia, hospital-acquired pneumonia, visible/gross aspiration pneumonia, suspected active viral infection, fungal infection, active tuberculosis of the lung)
    4. Non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
    5. Pleural empyema (not including sterile parapneumonic effusions)
    6. Microbiologically-documented infection with a pathogen known to be resistant to ceftriaxone, or epidemiological or clinical context suggesting high likelihood of a ceftriaxone-resistant “typical” bacterial pathogen (e.g. Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus)
    7. Previous treatment with an antimicrobial for treatment of CAP within 96 hours leading up to randomization

    EXCEPTIONS: subjects may be eligible despite prior antimicrobial therapy if they meet the following conditions:

    EITHER:

    • A single dose of an oral cephalosporin; amoxicillin-clavulanate or other penicillin; clarithromycin or erythromycin (note: not including longer acting macrolides/ ketolides – i.e. azithromycin or telithromycin); or IV cefotaxime (short-acting cephalosporin)

    OR BOTH OF THE FOLLOWING:
    • Unequivocal clinical evidence of treatment failure (e.g. worsening signs and symptoms) following at least 48 hours of prior systemic antimicrobial therapy
    • Isolation of an organism resistant to the prior, systemic, antimicrobial therapy

    8. Failure of ceftriaxone (or other third-generation cephalosporin) as therapy for this episode of CAP, or prior isolation of an organism resistant in vitro to ceftriaxone
    9. History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial
    10. Past or current history of epilepsy or seizure disorder

    EXCEPTIONS: well-documented febrile seizure of childhood

    11. Requirement for concomitant antimicrobial or systemic antifungal therapy for any reason

    EXCEPTIONS: topical antifungal or antimicrobial therapy, single oral dose of any antifungal for treatment of vaginal candidiasis

    12. Neoplastic lung disease, cystic fibrosis, progressively fatal disease, chronic neurological disorder preventing clearance of pulmonary secretions, or life expectancy of less than or equal to 3 months
    13. Probenecid administration within 3 days prior to initiation of study drug therapy or requirement for concomitant therapy with probenecid
    14. Infections or conditions requiring concomitant systemic corticosteroids

    EXCEPTIONS: the corticosteroid dose equivalent is less than 40 mg prednisone per day

    15. Severely impaired renal function (CrCl ≤ 30 mL/min) estimated by the Cockroft-Gault formula
    16. Evidence of significant hepatic, hematological, or immunologic disease (see definitions)
    17. Evidence of immediately life-threatening disease, including, but not limited to, current or impending respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g. diabetic ketoacidosis), or acute cerebrovascular events
    18. Residence in a nursing home or assisted living facility that provides 24-hour medical supervision (not including extended living facilities for ambulatory elderly persons) or hospitalization within 14 days prior to onset of symptoms (i.e. healthcare-associated pneumonia)
    19. Women who are pregnant or nursing
    20. Participation in any study involving administration of an investigational agent or device within 30 days prior to randomization into this study or previously participated in the current study
    21. Previous participation in a study of ceftaroline
    22. Unable or unwilling to adhere to the study-specified procedures and restrictions
    23. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome measure will be the per-subject overall (combined clinical and radiographic) success rate at the TOC visit in the CE and MITT populations. Overall response is defined as the combined clinical and radiographic responses. Subjects will be considered clinically cured at the TOC visit if they have total resolution of all signs and symptoms of the baseline infection, or improvement of the infection to such an extent that no further antimicrobial therapy is necessary. Radiographic success will be determined if the TOC visit CXR or chest CT scan is resolved, improved, or stable compared to the baseline CXR or CT scan. The overall response will be assessed programmatically by combining the clinical response with the radiographic response. To be an overall success the subject must be deemed a clinical cure and either a radiographic success or a radiographic indeterminate.

    The secondary efficacy outcome measures will be as follows:
    • Per-subject clinical cure rate at the TOC visit in the MITT, clinical MITT (cMITT), and CE populations
    • Per-subject clinical cure rate at the EOT visit in the MITT, cMITT, and CE populations
    Per-subject microbiological success rate at the TOC visit in the microbiological MITT (mMITT) and Microbiologically Evaluable (ME) populations
    • Per-pathogen clinical cure rate at the TOC visit in the mMITT and ME populations
    • Per-pathogen microbiological success rate at the TOC visit in the mMITT and ME populations
    • Per-subject relapse rate at the LFU visit in the subset of subjects in the CE population who were clinically cured at the TOC visit
    • Per-subject re-infection or recurrence rate at the LFU visit in the subset of subjects in the ME population who had a favorable microbiological outcome (eradication or presumed eradication) at the TOC visit

    Safety endpoints are:
    Adverse Events, Serious Adverse Events, physical examinations, vital signs, Hematology evaluations, serum chemistry, Urinalysis, ECG's and concomitant medications.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) 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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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 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
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.1.1In 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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 510
    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 Decision2007-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-08-27
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