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    Summary
    EudraCT Number:2009-011466-29
    Sponsor's Protocol Code Number:CXA 101-03
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-09-29
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2009-011466-29
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelonephritis
    A.3.2Name or abbreviated title of the trial where available
    CXA-101-03
    A.4.1Sponsor's protocol code numberCXA 101-03
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    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 SponsorCalixa Therapeutics 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 nameCXA-101
    D.3.2Product code CXA-101
    D.3.4Pharmaceutical form Powder 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.3.10 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: 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 Fortum, 1g
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Export Ltd
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameCeftazidime
    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.3.10 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.8 Information on Placebo
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10037596
    E.1.2Term Pyelonephritis
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054088
    E.1.2Term Urinary tract infection bacterial
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062279
    E.1.2Term Urinary tract infection pseudomonal
    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 microbiological response at 6 to 9 days after treatment in subjects with complicated Urinary Tract Infection (cUTI) including pyelonephritis following a 7- to 10-day treatment regimen.
    E.2.2Secondary objectives of the trial
    - Evaluate the safety of CXA 101 in subjects with cUTI including pyelonephritis;
    - Determine the clinical response at 6 to 9 days after treatment in subjects with cUTI including pyelonephritis following a 7- to 10-day treatment regimen;
    - Evaluate the population plasma PK profile in subjects with cUTI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are each required to meet the following inclusion criteria:
    1. Males and females 18 to 90 years of age, inclusive. Females of childbearing potential must have a documented negative serum pregnancy test and be using a highly effective method of birth control.

    2. Pyuria (white blood cell [WBC] count > 10/µL in unspun urine or ≥ 10 per high power field in spun urine)

    3. Clinical signs and/or symptoms of cUTI, either of:
    a. Pyelonephritis, as indicated by both of the following:
    i. Fever (oral temperature ≥ 37.8°C);
    ii. Flank pain or costovertebral angle tenderness;
    OR
    b. Complicated lower UTI, as indicated by both of the following:
    i. At least one of the following new or worsening symptoms:
    • Dysuria;
    • Frequency;
    • Suprapubic pain;
    • Urgency.
    ii. At least one of the following complicating factors:
    • Male gender;
    • Current bladder instrumentation or indwelling urinary catheter that is expected to be removed during the course of IV study drug administration;
    • Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration;
    • Urogenital surgery within 7 days preceding administration of the first dose of study drug;
    • Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine.

    4. Have a pretreatment baseline urine culture specimen obtained within two calendar days 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.

    5. Require IV antibacterial therapy for the treatment of the presumed cUTI

    6. Provide written informed consent.
    E.4Principal exclusion criteria
    Subjects must each NOT meet any of the following exclusion criteria:
    1. Documented history of any hypersensitivity or allergic reaction to any β-lactam antibacterial

    2. Concomitant infection requiring systemic antibacterial therapy in addition to IV study drug therapy at the time of randomization. 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 more than one dose of a potentially therapeutic antibacterial agent for the treatment of the current UTI within 96 hours before obtaining the study- qualifying pretreatment baseline urine
    NOTE: Subjects receiving UTI prophylaxis are eligible to enroll if all other eligibility criteria are met, including obtaining a study-qualifying pretreatment baseline urine culture (see Section 7.3)

    5. Intractable infection anticipated to require more than 10 days of study drug therapy

    6. Complete, permanent obstruction of the urinary tract

    7. Confirmed (at time of randomization) fungal urinary tract infection (with ≥ 103 fungal CFU/mL)

    8. Permanent indwelling bladder catheter or instrumentation including nephrostomy

    9. Suspected or confirmed perinephric or intrarenal abscess

    10. Suspected or confirmed prostatitis

    11. Known ileal loop or vesico-ureteral reflux

    12. Moderate or severe impairment of renal function including a estimated CrCl < 50 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours)

    13. Current urinary catheter that will not be removed. (Intermittent straight catheterization after the IV study drug administration period is acceptable)

    14. Any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of study data

    15. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure, and septic shock

    16. Immunocompromising condition, including known infection with human immunodeficiency virus (HIV), 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 for more than 14 days preceding randomization

    17. One or more of the following laboratory abnormalities in baseline specimens: AST, ALT, or alkaline phosphatase level greater than 3 times the upper limit of normal (ULN), total bilirubin greater than 2 times ULN, absolute neutrophil count less than 1000/μL, platelet count less than 50,000/μL, or hematocrit less than 25%

    18. Clinically significant abnormality in baseline ECG

    19. Participation within the last 30 days in any clinical study of an investigational product

    20. Previous participation in any study of CXA 101\

    21. Women who are pregnant or nursing
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the per-subject microbiological response at the Test of Cure (TOC) visit in the microbiologically evaluable (ME) and microbiological modified intent-to-treat (mMITT) populations.

    The Intent-to-Treat (ITT) Population will consist of all randomized subjects

    The Modified Intent-to-Treat Population (MITT) Population is the same as the ITT Population and consists of all randomized subjects who receive any amount of study drug.

    The Microbiological Modified Intent-to-treat (mMITT) Population will be a subset of the
    MITT Population and include subjects who have at least one acceptable causative
    pathogen from a study-qualifying pretreatment baseline urine specimen or a blood
    culture.

    The ME Population will be a subset of the mMITT Population and will include subjects
    who meet all the following conditions:
    • Met the minimal disease criteria (defined by inclusion criterion 2);
    • Had no protocol deviation likely to impact the microbiological outcome,
    including receiving a confounding non-study antibacterial agent. A
    confounding nonstudy antibacterial agent is one, with potential activity
    against the subject’s baseline uropathogen and that was given systemically at
    any time from the time of the study-qualifying baseline culture through the
    TOC visit.
    • Received an appropriate duration of study drug therapy or was classified as
    an evaluable microbiologic failure after completing at least 3 days of study
    drug therapy;
    • Had an interpretable urine culture at the TOC visit. Urine cultures that were
    repeated within 7 days of the TOC visit because of contamination of the
    original specimen are acceptable.
    • Attended the TOC visit 6 to 9 days after EOT or subject was classified as a
    microbiological failure before the TOC visit.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    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 months6
    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 months6
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 120
    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 Decision2009-12-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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