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    Summary
    EudraCT Number:2010-023452-87
    Sponsor's Protocol Code Number:CXA-cUTI-10-04
    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:2011-02-25
    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 number2010-023452-87
    A.3Full title of the trial
    A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PHASE 3 STUDY TO COMPARE THE SAFETY AND EFFICACY OF INTRAVENOUS CXA 201 AND INTRAVENOUS LEVOFLOXACIN IN COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test a new antibiotic given by vein to be used for Complicated
    Urinary Tract infections by comparing it to a well known antibiotic,
    levofloxacin.
    A.4.1Sponsor's protocol code numberCXA-cUTI-10-04
    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 SponsorCubist Pharmaceuticals, 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 supportCubist Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPRA
    B.5.2Functional name of contact pointPaul Starkey
    B.5.3 Address:
    B.5.3.1Street AddressDynamostr. 13 - 15
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post codeD-68165
    B.5.3.4CountryGermany
    B.5.4Telephone number+44 179 252 5608
    B.5.5Fax number+49 621 8782 181
    B.5.6E-mailMedicEU@PRAIntl.com
    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 nameCXA-201
    D.3.2Product code CXA-201
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNCXA-101
    D.3.9.1CAS number 936111-69-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number1000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTazobactam
    D.3.9.1CAS number 89786-04-09
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number500
    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 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 Tavanic (Levofloxacin)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Germany 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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNLEVOFLOXACIN
    D.3.9.1CAS number 100986854
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number5
    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
    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
    Complicated Urinary Tract Infection, Including Pyelonephritis
    E.1.1.1Medical condition in easily understood language
    Urinary Tract infections in complicated conditions like kidney infections,
    people with catheters, and other complicating factors.
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of CXA-201 versus comparator (levofloxacin) in adult subjects with cUTI (including pyelonephritis) based on the difference in composite microbiological eradication and clinical cure rate in the mMITT population at the test-of-cure (TOC) visit (7 days [± 2 days] after last treatment) (CXA-201 minus comparator [levofloxacin]), using a non inferiority margin of 10%.
    E.2.2Secondary objectives of the trial
    • To demonstrate the non-inferiority of CXA-201 versus comparator (levofloxacin) in adult subjects with cUTI (including pyelonephritis) based on the difference in composite microbiological eradication and clinical cure rate in the ME population at the TOC visit (7 days [± 2 days] after last treatment) (CXA-201 minus comparator [levofloxacin]), using a non-inferiority margin of 10%
    • To compare the clinical and microbiological response of CXA-201 versus comparator
    (levofloxacin) at the end of therapy (EOT), TOC, and late follow up (LFU; 28 35 days post last dose of study drug) visits
    • Evaluate the safety of CXA-201 in subjects with cUTI (including pyelonephritis).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines).
    2. Be males or females ≥ 18 years of age.
    3. If female, subject is non-lactating, and is either:
    a. Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or b. Of childbearing potential and is practicing a barrier method of birth control (e.g., a diaphragm or contraceptive sponge) along with 1 of the following methods: oral or parenteral contraceptives (for 3 months prior to study drug administration), or a vasectomized partner. Or, subject is practicing abstinence from sexual intercourse.
    Subjects must be willing to practice these methods for the duration of the trial and for at least 35 days after last dose of study medication.
    4. Males are required to practice reliable birth control methods (condom or other barrier device) during the conduct of the study and for at least 35 days after last dose of study medication.
    5. Pyuria (white blood cell [WBC] count > 10/μL in unspun urine or ≥ 10 per high power field in spun urine).
    6. Clinical signs and/or symptoms of cUTI, either of:
    a. Pyelonephritis, as indicated by at least 2 of the following:
    i. Documented fever (oral temperature > 38°C) accompanied by patient symptoms
    of rigors, chills, or “warmth”;
    ii. Flank pain or suprapubic pain;
    iii. Costovertebral angle tenderness or suprapubic tenderness on physical exam;
    iv. nausea or vomiting; or
    v. dysuria, urinary frequency or urinary urgency;
    OR
    b. Complicated lower UTI, as indicated by at least 2 of the following:
    i. At least 2 of the following new or worsening symptoms of cUTI:
    1. Dysuria; urinary frequency or urinary urgency;
    2. Documented fever (oral temperature > 38°C) accompanied by patient
    symptoms of rigors, chills, or “warmth”;
    3. Suprapubic pain or flank pain;
    4. Costovertebral angle tenderness or suprapubic tenderness on physical
    exam; or
    5. Nausea or vomiting; plus,
    ii. At least 1 of the following complicating factors:
    1. Males with documented history of urinary retention;
    2. Indwelling urinary catheter that is scheduled to be removed during IV
    study therapy and before the EOT;
    3. Current obstructive uropathy that is scheduled to be medically or
    surgically relieved during IV study therapy and before the EOT; or
    4. Any functional or anatomical abnormality of the urogenital tract
    (including anatomic malformations or neurogenic bladder) with voiding
    disturbance resulting in at least 100 mL residual urine.
    7. Have a pretreatment baseline urine culture specimen obtained within 24 hours before the start of
    administration of the first dose of study drug.
    NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows the results of the baseline urine culture.
    8. Require IV antibacterial therapy for the treatment of the presumed cUTI.
    E.4Principal exclusion criteria
    1. Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibacterial (a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment).
    2. Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., vancomycin, linezolid] are allowed.)
    3. Receipt of any amount of potentially therapeutic antibacterial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug.
    4. Receipt of any dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 48 hours before the study-qualifying pretreatment baseline urine is obtained (exceptions: subjects with an active cUTI who have received prior antibiotics may be enrolled provided a minimum of 48 hours have elapsed between the last dose of the prior antibiotic and the time of
    obtaining the baseline urine specimen. Subjects receiving current antibiotic prophylaxis for cUTI who present with signs and symptoms consistent with an active new cUTI may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture).
    5. Intractable urinary infection at baseline that the Investigator anticipates would require more than 7 days of study drug therapy.
    6. Complete, permanent obstruction of the urinary tract.
    7. Confirmed fungal urinary tract infection at time of randomization (with ≥ 103 fungal CFU/mL).
    8. Permanent indwelling bladder catheter or urinary stent including nephrostomy.
    9. Suspected or confirmed perinephric or intrarenal abscess.
    10. Suspected or confirmed prostatitis.
    11. Known ileal loop or vesico-ureteral reflux.
    12. Severe impairment of renal function including an estimated creatinine clearance (CrCl 13. ) < 30 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours).
    14. Current urinary catheter that is not scheduled to be removed before the EOT (intermittent straight catheterization during the IV study drug administration period is acceptable).
    15. Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data.
    16. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock.
    17. Immunocompromising condition, including established Acquired Immune Deficiency Syndrome (AIDS), hematological malignancy, or bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, or the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day
    administered continuously for more than 14 days preceding randomization.
    18. One or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase, or total bilirubin level greater than 3 times the upper limit of normal (ULN), absolute neutrophil count less than 500/μL, platelet count less than 40,000/μL, or hematocrit less than 20%.
    19. Participation in any clinical study of an investigational product within 30 days prior to the proposed first day of study drug.
    20. Previous participation in any study of CXA-101 or CXA-201.
    21. Women who are pregnant or nursing.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint
    • Composite microbiological eradication and clinical cure rate in the mMITT population at the TOC
    visit
    Key Secondary Efficacy Endpoints
    • Composite microbiological eradication and clinical cure rate in the ME population at the TOC visit
    • Clinical response CXA-201 versus comparator (levofloxacin) at the end of therapy (EOT), test-ofcure
    (TOC), and late follow up (LFU; 28 35 days post last dose of study drug) visits
    • Microbiological response of CXA-201 versus comparator (levofloxacin) at the end of therapy
    (EOT), test-of-cure (TOC), and late follow up (LFU; 28 35 days post last dose of study drug) visits
    • Per-pathogen microbiological eradication rates
    Safety Endpoints
    Safety will be evaluated in the safety population through review of summaries of :
    • AEs
    • Laboratory evaluations
    • Vital signs
    • Physical examinations
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary statistical goal of this study is to establish non-inferiority of CXA-201 to levofloxacin with respect to the proportion of subjects in the mMITT population who achieve both microbiological eradication and clinical cure (primary efficacy endpoint) at the TOC. A 95% CI (normal approximation to the binomial distribution) around the treatment difference (CXA-201 minus levofloxacin) will be calculated. CXA-201 will be
    considered non-inferior to levofloxacin if the lower limit of the 95% CI around the treatment difference (CXA-201 minus levofloxacin) is greater than minus 10%.
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints
    • Composite microbiological eradication and clinical cure rate in the ME
    population at the TOC visit
    • Clinical response CXA-201 versus comparator (levofloxacin) at the end
    of therapy (EOT), test-ofcure (TOC), and late follow up (LFU; 28 35 days post last dose of study drug) visits
    • Microbiological response of CXA-201 versus comparator (levofloxacin)
    at the end of therapy (EOT), test-of-cure (TOC), and late follow up (LFU; 28 35 days post last dose of study drug) visits
    • Per-pathogen microbiological eradication rates
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary statistical goal is to establish non-inferiority of CXA-201 to levofloxacin with respect to the composite microbiological eradication and clinical cure rate in the ME at TOC population. A 95% CI (normal approximation to the binomial distribution) around the treatment difference (CXA-201 minus levofloxacin) will be calculated. CXA-201 will be considered non-inferior to levofloxacin if the lower limit of the 95% CI around the treatment difference (CXA-201 minus levofloxacin) is greater than minus 10%. As sensitivity analyses, an appropriate statistical method (e.g., propensity score) will be used to adjust for potential confounding covariates associated with treatment assignment when constructing CIs around the treatment differences.
    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 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 Yes
    E.8.1.7.1Other trial design description
    Double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Levofloxacin
    E.8.2.4Number of treatment arms in the trial2
    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 EEA37
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Colombia
    Georgia
    Germany
    Hungary
    Israel
    Italy
    Mexico
    Moldova, Republic of
    Romania
    Serbia
    Slovakia
    South Africa
    Thailand
    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 stopped when the last subject included in the double-blind treatment period completes the study or when the last ongoing subject has discontinued treatment, whichever occurs first.
    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 months7
    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 months9
    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.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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: 652
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 299
    F.4.2.2In the whole clinical trial 776
    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)
    The Investigator must ensure that the investigational product will be used only in accordance with the protocol. It is forbidden to use investigational drug material for purposes other than as defined in this protocol.
    All subjects who discontinue the study medication should be offered alternative treatment if applicable. Treatment should be given according to normal clinical practice, after a termination visit.
    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 Decision2011-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-04
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