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    Summary
    EudraCT Number:2006-000874-56
    Sponsor's Protocol Code Number:BAY12-8039/11976
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-12
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2006-000874-56
    A.3Full title of the trial
    A prospective, randomized, double dummy, double blind, multi-center trial comparing the safety and efficacy of moxifloxacin 400 mg IV QD 24 hours to that of ertapenem 1.0 g IV QD 24 hours for 5 to 14 days for the treatment of subjects with complicated intra-abdominal infections.
    A.3.2Name or abbreviated title of the trial where available
    PROMISE
    A.4.1Sponsor's protocol code numberBAY12-8039/11976
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Avalox 400 mg/250 ml Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital 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 nameMoxifloxacin
    D.3.2Product code BAY 12-8039
    D.3.4Pharmaceutical form 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 INNmoxifloxacin
    D.3.9.2Current sponsor codeBay 12-8039
    D.3.9.3Other descriptive nameAvalox
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.6
    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 Yes
    D.3.11.13.1Other medicinal product typeantiinfective
    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 Invanz
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 nameErtapenem
    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 INNertapenem
    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 Yes
    D.3.11.13.1Other medicinal product typeantiinfective
    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
    D.8 Placebo: 2
    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 intra-abdominal Infections
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10056570
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to compare the safety and efficacy of intravenous moxifloxacin 400 mg administered once daily with those of intravenous ertapenem 1 g once a day in adult subjects with cIAI that require surgery and parenteral antibiotic therapy

    The primary efficacy variable for this trial is the clinical response 21 to 28 days after the completion of study drug therapy (Test of Cure visit).
    E.2.2Secondary objectives of the trial
    Secondary efficacy parameters are:
    • Clinical and bacteriological response on treatment Day 5 +/- 1.
    • Clinical and bacteriological response at the End-of-Therapy (EOT).
    • Bacteriological response at the TOC visit (21 28 days after EOT).
    • Clinical response at the TOC visit in subjects with a bacteriologically documented intra abdominal infection.
    • Mortality attributable to intra abdominal infections at the time of the TOC visit (21 to 28 days after EOT).
    • Duration of hospitalization (total days).
    • Duration of hospitalization postoperatively (days).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria:
    1. Hospitalized men or women >/= 18 years of age.
    2. Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days.
    3. Documented and signed written informed consent. Consent may also be provided by a subject’s legally acceptable representative/guardian/parent (in accordance with local law).
    4. Confirmed or suspected intra abdominal infection defined as follows:
    . For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following:
    • Gross peritoneal inflammation with purulent exudates (ie, peritonitis).
    • Intra abdominal abscess.
    • Macroscopic intestinal perforation with localized or diffuse peritonitis.
    Subjects enrolled on the basis of a suspected intra abdominal infection must have:
    1. Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess
    and
    2. The following signs and symptoms:
    • At least one symptom referable to the abdominal cavity (eg, nausea, vomiting, distension or pain), lasting for at least 24 hours.
    • At least one of the following signs: tenderness (with or without rebound), absent or diminished bowel sounds, abdominal wall rigidity
    • At least two of the following SIRS criteria (23):
    .Temperature > 38.3°C rectal or tympanic membrane, or temperature > 37.8.0°C oral or >37.3 for axillary.
    . Heart rate > 90/min.
    . Respiratory rate > 20/min.
    . WBC >12,000 cells/mm3 or < 4,000 cells/ mm3.
    and
    3. The subject must be scheduled for a surgical procedure (laparotomy or
    laparoscopy) within 24 hours of enrollment in the study.
    E.4Principal exclusion criteria
    1) Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (eg, penicillins or cephalosporins), or any of the excipients.
    2) Women who are pregnant or lactating or in whom pregnancy cannot be excluded (Note: a urine pregnancy test has to be performed for all women of childbearing potential before inclusion into the study).
    3) History of tendon disease/disorder related to quinolone treatment.
    4) Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias.
    5) Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (eg, quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (eg, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (eg, phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil).
    6) Known severe hepatic insufficiency (Child Pugh C, see Appendix 10.2) or transaminase increase > 5 fold upper limit of normal (ULN).
    7)Creatinine clearance </= 30 mL/min/1.73 m2 (the Cockroft-Gault formula for calculating creatinine clearance is given in Appendix 10.5).
    8) Systemic antibacterial therapy administered for more than 24 hours within 7 days prior to treatment with study medication.
    9)Need for systemic antibacterial therapy with agents other than those described in the study protocol (Note: prophylactic anti-fungal therapy is accepted).
    10) Indwelling peritoneal catheter or vascular shunt
    11)Pre existing ascites and presumed spontaneous bacterial peritonitis.
    12) Perforation of the stomach or duodenum, if the duration of perforation (based on first symptoms as reported by the subject) is less than 24 hours or if operated on within 24 hours of perforation.
    13) Perforation of the small bowel (excluding the duodenum) or large bowel, if the duration of perforation (based on first symptoms as reported by the subject) is less than 12 hours.
    14) All pancreatic processes including pancreatic sepsis, peri-pancreatic sepsis, or an intra abdominal infection secondary to pancreatitis.
    15) Liver and splenic abscess.
    16) Transmural bowel ischemia or necrosis without perforation or established peritonitis or abscess.
    17) Acute and gangrenous cholecystitis without perforation.
    18) Acute cholangitis.
    19) Appendicitis as the source of the complicated intraabdominal infection, and therefore all types of appendicitis, with or without perforation, intaabdominal abscess or peritonitis.
    20) Subjects requiring antibiotic irrigations (including prophylactic antibiotic irrigations) of the abdominal cavity or surgical wound
    21) Treatment with "open abdomen" or marsupialization, or multiple planned re laparotomies.
    22) Infections originating from the female genital tract.
    23) Peri-nephric infections.
    24) Evidence of sepsis with shock requiring the administration of moderately high or high doses of vasopressors for more than 12 consecutive hours. Low doses of vasopressors (eg., <5 µg/kg/min for dopamine or <0.2 µg/kg/min for noradrenaline) are accepted for any period of time as well as moderately high or high doses of vasopressors for less than 12 consecutive hours, provided that the patient is hemodynamically stable.
    25) Known rapidly fatal underlying disease (death expected within 6 months).
    26) Neutropenia (neutrophil count < 1,000/µL) caused by immunosuppressive therapy or malignancy.
    27) Receiving chronic treatment with known immunosuppressant therapy (including chronic treatment with > 15 mg/day of systemic prednisone or equivalent).
    28) Subjects known to have AIDS (CD4 count < 200/µL) or HIV seropositives who are receiving HAART (Note: HIV positive subjects may be included. HIV testing is not required for this study protocol).
    29) Subjects with a malignant or pre malignant hematological condition, including Hodgkin’s disease and non-Hodgkin lymphoma (subjects with solid tumor can be included in the study).
    30) Subjects with a Body Mass Index >/= 45 kg/m2 [BMI = weight (in kg)/height (in m)2]
    31) Previous enrollment in this study.
    32) Participation in any clinical investigational drug study within the previous 4 weeks.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for this trial is the clinical response 21 to 28 days after the completion of study drug therapy (Test of Cure 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 No
    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 No
    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) 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 EEA35
    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
    End of Trial is defined as Clean Database
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 2006-04-12. 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects confirmed as having cIAI during a surgery procedure prior to obtaining informed consent. Informed Consent will be collected after surgery to be randomized and continue into the trial.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 522
    F.4.2.2In the whole clinical trial 845
    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)
    As the study medication is an antibiotic substance, the underlying disease (intraabdominal infection) is supposed to be resolved after the study treatment is being completed. However, if applicable, after participation in the trial, patients will be treated with the current standard therapy.
    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 Decision2006-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-25
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