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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).

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    Summary
    EudraCT Number:2006-005332-25
    Sponsor's Protocol Code Number:P903-06
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-12-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-005332-25
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin plus Aztreonam in Adult Subjects with Complicated Skin and Skin Structure Infection
    A.4.1Sponsor's protocol code numberP903-06
    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) 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.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 VANCOMYCINE MERCK 1 g, poudre pour solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderMerck
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 INNVANCOMYCIN HYDROCHLORIDE
    D.3.9.1CAS number 1404939
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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.IMP: 3
    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 Azactam
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb GmbH & Co. KGaA
    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 nameAzactam
    D.3.2Product code aztreonam
    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 INNAZTREONAM
    D.3.9.1CAS number 78110380
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARGININE
    D.3.9.1CAS number 74793
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number814
    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 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 Skin and Skin Structure Infections (cSSSI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10052891
    E.1.2Term Skin bacterial infection
    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 clinical cure rate of ceftaroline treatment compared with that of vancomycin plus aztreonam treatment at the Test of Cure (TOC) visit in Clinically Evaluable (CE) and Clinically Modified Intent-to-Treat (cMITT) populations of adult subjects with cSSSI.
    E.2.2Secondary objectives of the trial
    · Evaluate the in microbiological success (eradication or presumed eradication) rate of ceftaroline treatment compared with that of vancomycin plus aztreonam treatment at the TOC visit
    · Evaluate the clinical response at the End-of-Therapy (EOT) visit
    · Evaluate the clinical and microbiological response by pathogen at the TOC visit
    · Evaluate clinical relapse at the Late Follow-up visit (LFU) visit
    · Evaluate the microbiological re-infection or recurrence at the LFU visit
    · Evaluate safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age greater than or equal to 18 years
    2. Skin and skin structure infection (SSSI) that meets EITHER of the following criteria:Involves deeper soft tissue or requires significant surgical intervention, such as a wound infection (surgical or traumatic), a major abscess, an infected ulcer, or deep and extensive cellulitisORCellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease (PVD)
    3. Three or more of the following clinical signs:
    · Purulent or seropurulent drainage or discharge
    · Erythema
    · Fluctuance
    · Heat or localized warmth
    · Pain or tenderness to palpation
    · Fever greater than 38ºC oral (> 38.5ºC rectally or tympanically) or hypothermia (< 35ºC)
    · White Blood Cell (WBC) count greater than 10,000/mm3
    · Greater than 10% immature neutrophils (bands) irrespective of WBC count
    4. The subject must require initial hospitalization, or treatment in an emergency room or urgent care setting, by the standard of care. Exception: subjects suitable for outpatient antimicrobial therapy (OPAT) may be enrolled with approval of the Medical Monitor
    5. The subject’s infection is expected to require at least 5 days of IV antibiotic therapy.
    6. Female subjects of child-bearing potential who are less than 2 years post-menopausal must agree to and comply with using highly effective methods of birth control ( e.g., condom +/- spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study.
    7. Written informed consent, willingness, and ability to comply with all study procedures.
    E.4Principal exclusion criteria
    1. Documented History of any hypersensitivity or allergic reaction to any ß-lactam antibiotic
    2. Documented History of any hypersensitivity or allergic reaction to vancomycin or aztreonam
    3. Past or current history of epilepsy or seizure disorder, excluding well-documented febrile seizure of childhood
    4. More than 24 hours of treatment with a non-study antimicrobial (other than topical antibiotics) for the treatment of current cSSSI within 96 hours prior to randomization. EXCEPTION: Subjects may be eligible if they meet BOTH of the following conditions:
    · Clinical evidence of failure following at least 48 hours of prior systemic antibiotic therapy
    AND
    · Microbiological evidence of failure
    5. Failure of vancomycin or aztreonam as therapy for cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam
    6. Uncomplicated SSSI such as simple abscess, impetiginous lesions, superficial cellulitis, furunculosis, carbunculosis, or folliculitis. Skin and skin structure infections with a high cure rate after surgical incision alone or after aggressive local skin care (e.g., surgical site infection with a margin of less than 5 cm of surrounding cellulitis).
    7. Skin and skin structure infection with ANY of the following characteristics:· -Known or suspected anaerobic pathogens (e.g., perirectal abscess)·
    -Known or suspected fungal, parasitic, or viral pathogens·
    -Known or suspected Pseudomonas aeruginosa as a contributing pathogen·
    -Involving a decubitus ulcer·
    -Involving a diabetic foot ulcer or an ulcer associated with PVD that has the following characteristics:
    o Accompanied with osteomyelitis
    o Likely to require amputation within 60 days
    o Likely to require revascularization within 60 days
    -Requiring significant surgical intervention that cannot be performed within 48 hours after initiating study drug therapy.
    -Cases of cellulitis with a surface area less than 10 cm2 or a history consistent with clinical improvement or stabilization.
    -Involving a third-degree burn or a burn covering more than 5% of total body surface area· Involving an underlying inflammatory skin disease that may obscure determination of response
    -Involving human or animal bites (infections associated with arthropod bites may be allowed)
    -Involving a rapidly necrotizing process, such as necrotizing fasciitis·
    -Involving gangrene of any etiology
    -Complicated by the presence of prosthetic materials that will not be removed, such as central venous catheters, permanent cardiac pacemaker battery packs, or joint replacement prostheses
    -Likely to require amputation
    8. Known or suspected endocarditis, osteomyelitis, or septic arthritis
    9. Requirement for concomitant antibacterial or systemic antifungal therapy for any reason EXCEPTIONS: topical antiseptics (e.g., povidone-iodine [Betadine™], chlorhexidine [Hibiclens™], and alcohol and soaps for wound care), topical antifungal therapy, or a single oral dose of any antifungal for treatment of vaginal candidiasis are allowed.
    10. Probenecid administration within 3 days prior to initiation of study drug or requirement for concomitant probenecid administration
    11. Infections or conditions requiring concomitant systemic corticosteroid therapy at a dose equivalent to or greater than prednisone 40 mg per day
    12. Severely impaired renal function (CrCl < 30 mL/min) estimated by the Cockroft-Gault formula
    13. Evidence of significant hepatic, hematologic, or immunologic disease determined by the following:
    · Aspartate aminotransferase (AST, GOT) or ALT (GPT) level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal
    · Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
    · Current or anticipated neutropenia (< 500 neutrophils/mm3)· Thrombocytopenia with platelet count less than 60,000 cells/mm3· Known infection with human immunodeficiency virus and either a CD4 count less than or equal to 200 cells/ mm3 or another Acquired Immune Deficiency Syndrome-defining illness
    · Bone marrow-ablative chemotherapy or radiation therapy within the prior 3 months
    14. Evidence of immediate life-threatening disease
    15. Life expectancy less than 3 months
    16. Women who are pregnant or nursing
    17. Participation in any study involving administration of an investigational agent within 30 days prior to randomization into this study
    18. Previous participation in a study of ceftaroline
    19. Unable or unwilling to adhere to the study-specified procedures and restrictions
    20. 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 is the per subject clinical cure at the Test-of-Cure (TOC) visit in the Clinically Evaluable (CE) and Clinical Modified Intent-to-Treat (cMITT) populations.

    Secondary efficacy endpoints are:
    Per-subject clinical cure rate at the EOT visit in the CE population
    Per-subject clinical cure rate at the EOT visit in the cMITT population
    Per-subject microbiological response at the TOC visit in the microbiological Modified intent-to-Treatment (mMITT) population
    Per-subject microbiological response at the TOC visit in the Microbiologically Evaluable (ME) population
    Per-subject relapse at the LFU visit in those subjects who were clinically cured at the TOC visit
    Per-subject re-infection or recurrence at the LFU visit in those subjects who had a favourable microbiological outcome (eradication or presumed eradication) at the TOC visit.

    Safety Endpoints are:
    Adverse Events
    Serious Adverse Events
    Physical Examinations
    Vital Signs
    ECG’s
    Urinalysis
    Hematology
    Serum Chemistries
    Concomitant Medications
    Concomitant Antimicrobials
    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 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 Yes
    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 concerned9
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.5.1Number of sites anticipated in the EEA50
    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 months4
    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 months4
    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 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 state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 267
    F.4.2.2In the whole clinical trial 690
    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 Decision2007-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
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