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    Summary
    EudraCT Number:2004-004573-29
    Sponsor's Protocol Code Number:DORI-06
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-12-17
    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 ConcernedAustria - BASG
    A.2EudraCT number2004-004573-29
    A.3Full title of the trial
    A Multicenter, Phase 3 Study to Confirm the Safety and Efficacy of Intravenous Doripenem in Complicated Lower Urinary Tract Infection or Pyelonephritis
    A.4.1Sponsor's protocol code numberDORI-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 SponsorPeninsula 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 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 namedoripenem
    D.3.2Product code S-4661
    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 INNdoripenem
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codedoripenem
    D.3.9.3Other descriptive nameS-4661
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/V) percent weight/volume
    D.3.10.2Concentration typeequal
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeß-lactam antibiotics
    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 Lower Urinary Tract Infection or Pyelonephritis
    MedDRA: Lower urinary tract infection or pyelonephritis (10024981 and/or 10059517)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10024981
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the microbiological response at 6-9 days post-therapy in patients with cUTI following a 10-day treatment regimen.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are to:
    • Determine the clinical response at 6-9 days post-therapy in patients with cUTI following a 10-day treatment regimen
    • Evaluate the safety of doripenem in patients with cUTI
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Be males or females >18 years of age
    Demonstrate clinical signs and/or symptoms of cUTI, either of:
    a. Pyelonephritis, as indicated by all three of the following:
    i. Fever (oral temperature ≥37.8°C)
    ii. Flank pain or costovertebral angle tenderness
    iii. Pyuria (>10 white blood cells [WBC] per µL in unspun urine or >10 WBC per high power field in spun urine)
    OR
    b. Complicated lower UTI, as indicated by all three of the following:
    i. At least one of the following symptoms:
    • Dysuria
    • Frequency
    • Suprapubic pain
    • Urgency
    ii. Pyuria (>10 WBC per µL in unspun urine or >10 WBC per high power field in spun urine)
    iii. At least one of the following complicating factors:
    • Male gender
    • Current bladder instrumentation or indwelling urinary catheter that is anticipated to be removed during the course of IV study drug administration
    • Obstructive uropathy that is anticipated to be medically or surgically treated during the course of IV study drug administration
    • Urogenital surgery within 7 days prior to 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
    Have a study-qualifying pretreatment baseline urine culture specimen obtained within 48 hours prior to the start of administration of the first dose of study drug from which a bacterial uropathogen is isolated with a growth of ≥105 CFU/mL.
    NOTE: Patients may be enrolled in this study and start IV study drug therapy prior to the investigator knowing the results of the baseline urine culture. However, if the final results of the baseline urine culture do not meet the definition of a study-qualifying pretreatment baseline urine culture, then the patient must be withdrawn from study drug therapy.
    Require antibacterial therapy for the treatment of the presumed cUTI
    Provide written informed consent. If the patient is unable to provide written informed consent, the patient’s legally accepted representative may provide written consent as approved by institution-specific guidelines.
    E.4Principal exclusion criteria
    1. Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control (e.g., condom, hormonal contraceptive, indwelling intrauterine device, sexual abstinence)
    2. History of moderate or severe hypersensitivity reactions to carbapenems, penicillins, other beta-lactam antibiotics or any quinolone (mild rash is not a contraindication to enrollment)
    3. Complete, permanent obstruction of the urinary tract
    4. Confirmed fungal urinary tract infection with a colony count ≥103 CFU/mL
    5. Permanent indwelling bladder catheter or instrumentation including nephrostomy
    6. Suspected or confirmed perinephric or intrarenal abscess
    7. Suspected or confirmed prostatitis
    8. Any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure, respiratory failure and septic shock
    9. Immunocompromising illness including known infection with human immunodeficiency virus (HIV), AIDS, hematological malignancy and bone marrow transplantation, or immunosuppressive therapy including cancer chemotherapy, medications for prevention of organ transplantation rejection, imuran and the administration of corticosteroids equivalent to or greater than 40 mg of prednisone per day administered for more than 14 days.
    10. Severe impairment of renal function including a calculated creatinine clearance of <10 mL/min, requirement for peritoneal dialysis, hemodialysis or hemofiltration or oliguria (<20 cc urine output per hour over 24 hours)
    11. One or more of the following laboratory abnormalities: aspartate aminotransferase, alanine aminotransferase, bilirubin or alkaline phosphatase levels >3 times the upper limit of normal (ULN), absolute neutrophil count of <500 per μL, platelet count of <40,000 per μL or hematocrit of <20%
    12. Known ileal loops or vesico-ureteral reflux
    13. Concomitant infection requiring systemic antibiotic or antifungal therapy in addition to IV study drug therapy at the time of assignment of a patient number. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable)
    14. Receipt of any amount of potentially therapeutic antimicrobial therapy after collection of the pretreatment baseline urine culture and before administration of the first dose of study drug
    15. Receipt of any amount of potentially therapeutic antibiotic for the treatment of the current UTI within 96 hours prior to obtaining the study-qualifying pretreatment baseline urine. (Exception: patients 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 6.3])
    16. Intractable infection anticipated to require more than 10 days of study drug therapy
    17. Current urinary catheter that will not be removed or anticipation of urinary catheter placement that will not be removed during the course of IV study drug administration. (Clarification: Intermittent straight catheterization after the IV study drug administration period is acceptable.)
    18. Known or suspected CNS disorder that may predispose to seizures or lower the seizure threshold (e.g. severe cerebral arteriosclerosis, epilepsy) or the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g. certain drug therapy, renal dysfunction)
    19. Participation in any study of an investigational drug or device within 30 days prior to study entry
    20. Previous participation in any study of doripenem
    21. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data.
    E.5 End points
    E.5.1Primary end point(s)
    Primary:
    • Microbiological response at the TOC visit in the microbiologically evaluable at TOC population
    Secondary:
    • Clinical response at the TOC visit in the clinically evaluable at TOC population
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    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 No
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 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 2004-12-17. 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 220
    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)
    No
    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 Decision2005-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-16
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