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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44132   clinical trials with a EudraCT protocol, of which   7324   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2007-003854-28
    Sponsor's Protocol Code Number:REP-FAR-006
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-12-11
    Trial 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 number2007-003854-28
    A.3Full title of the trial
    Prospective, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO, BID for 10 Days Versus Clarithromycin in the Treatment of Community-Acquired Pneumonia”
    A.4.1Sponsor's protocol code numberREP-FAR-006
    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 SponsorReplidyne, 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 nameFaropenem medoxomil
    D.3.2Product code REP319740
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFaropenem medoxomil
    D.3.9.1CAS number 141702-36-5
    D.3.9.2Current sponsor codeREP319740
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 to mg
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 typeFaropenem is synthetically derived from the core structures of penicillin and cephalosporin molecules
    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 Klaricid XL
    D.2.1.1.2Name of the Marketing Authorisation holderAbbot Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameclarithromycin
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNclarithromycin
    D.3.9.1CAS number 81103119
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 typeClarithromycin is a semi-synthetic derivative of erythromycin A.
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Community-acquired pneumonia. This disease can be defined as an acute lower respiratory tract infection not acquired in a hospital or a long-term care facility.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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 efficacy of faropenem medoxomil by establishing its non- inferiority to clarithromycin, in terms of clinical response rate, in the treatment of patients with CAP (community-acquired pneumonia) in the ITT (Intent to Treat) and modified Intent to Treat subjects mITT (modified Intent to Treat) populations
    - To evaluate the safety and tolerability profile of faropenem medoxomil 600 mg PO BID for 10 days in patients with CAP (community-acquired pneumonia)
    E.2.2Secondary objectives of the trial
    • To demonstrate the efficacy of faropenem medoxomil by establishing its non-inferiority to clarithromycin, in terms of clinical response rate, in the treatment of subjects with CAP in the CE and ME Populations
    • To demonstrate the efficacy of faropenem medoxomil by establishing its non-inferiority to clarithromycin, in terms of bacteriological response rate, in the treatment of subjects in the mITT and ME (Microbiologically Evaluable) Populations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant female 18 years of age or older
    2. Subjects with fever documented within the past 24 hours (PO >38oC/100.4oF; Axillary >37.5oC/99.5oF; TM or Rectal >38.5oC/101.2oF)
    3. Subjects who can produce an adequate (i.e., sputum Gram stain with >25 PMNs/LPF and <10 squamous epithelial cells/LPF) and purulent (i.e., cloudy and discolored) sputum specimen
    4. A CXR obtained within 24 hours prior to initiating IP therapy and showing the presence of a new or progressive pulmonary infiltrate(s)
    5. The presence of one (1) or more of the following clinical findings:
    • New or increased cough
    • Dyspnea or tachypnea (RR > 20 breaths per minute [bpm] but ≤ 30), particularly if progressive in nature
    • Pleuritic chest pain
    • Auscultatory findings on pulmonary examination of rales/rhonchi and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony)
    6. Subjects who are able to take oral medication
    7. If female of childbearing potential, the subject must:
    • have maintained her normal menstrual pattern during the 3 months prior to trial entry, AND
    • have taken hormonal contraceptives for at least 1 month prior to trial entry, or agree to use spermicide and barrier methods or have been using another acceptable method of contraception and agree to continue with the same method during the trial, AND
    • have had a negative urine β- subunit hCG pregnancy test sensitive to at least 50 µU/mL of β- hCG immediately prior to trial entry
    NOTE: Female subjects who have a positive pregnancy test and become pregnant during the trial must be promptly withdrawn from the trial
    8. Read and sign ICF and, if applicable, any local data privacy requirements. By signing the ICF, the subject agrees to release any medical records pursuant to all current local data privacy requirements.
    E.4Principal exclusion criteria
    1. Subjects with a history of hypersensitivity to faropenem medoxomil or clarithromycin or a history of an anaphylactic reaction to β-lactams (e.g., penicillins, cephalosporins or carbapenems) or allergy to the macrolide family of antimicrobials
    2. Subjects with a positive urinary antigen test for L. pneumophila at the Pre Therapy visit (Visit 1)
    3. Subjects with one (1) or more of the following:
    • Respiratory rate of > 30 bpm
    • Systolic blood pressure (SBP) < 90 mm Hg or diastolic blood pressure (DBP) < 60 mm Hg
    • Altered mental status (e.g., new disorientation to person, place or time, lethargy, stupor, coma)
    • Require mechanical ventilation
    • Require vasopressors to maintain blood pressure or urinary output
    4. Subjects with known bronchial obstruction or a history of post-obstructive pneumonia (does not exclude subjects with COPD)
    5. Subjects with known primary or metastatic malignancy in lung and/or pleura within the past 5 years
    6. Subjects with known or suspected bronchiectasis, cystic fibrosis, lung abscess, empyema, aspiration pneumonia, acute pulmonary embolism or collagen vascular disease affecting the lungs
    7. Subjects with known or suspected HIV infection, opportunistic infections such as toxoplasmosis, cryptococcal meningitis, tuberculosis, histoplasmosis, Pneumocystis jiroveci pneumonia, cytomegalovirus infection, oropharyngeal candidiasis (thrush), cryptosporidiosis, Mycobacterium avium complex infection, Kaposi’s sarcoma
    8. Subjects with known underlying condition(s) or disease(s) that would interfere with oral absorption of the IP
    9. Subjects residing in a long-term care facility within 4 weeks of the start of the IP (e.g., nursing home, etc.)
    10. Immunocompromised subjects, including but not limited to subjects with:
    • Known WBC count (< 2000 cells/mm3) or CD4 count of < 200 cells/mm3, or on highly active antiretroviral therapy. An HIV test is not required
    • Chronic corticosteroid therapy (> 20 mg/day of prednisone or equivalent for more than 3 months before trial entry)
    • Splenectomized subjects or subjects with known hyposplenia or asplenia
    11. Subjects who have been treated (> 24 hours) with oral or parenteral antibiotics within 14 days prior to enrollment or who plan to take antibiotics other than IP during the trial period
    12. Subjects who require parenteral antimicrobial therapy for the treatment of pneumonia
    13. Subjects who have been hospitalized for > 48 hours for any cause within two weeks prior to trial entry
    14. Subject has known renal insufficiency (calculated Creatinine Clearance [CrCl] < 30 mL/min) and/or severe hepatic insufficiency (Childs-Pugh Class C)
    15. Subjects with life expectancy < 3 months
    16. Subjects who have been previously treated under this Protocol
    17. Subjects who are pregnant and/or breastfeeding
    18. Subjects who have received any experimental drug or medical device within the previous 30 days (or are scheduled to receive any other experimental procedures during the trial period)
    19. Employees and/or family members of the Investigator or trial center with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center
    E.5 End points
    E.5.1Primary end point(s)
    The primary analyses will be the comparison of the clinical response rates of faropenem medoxomil to clarithromycin at the Test-of-Cure visit in the ITT (Intent to Treat ) and mITT (modified Intent to Treat) Populations.
    A comparison of the incidence of adverse events for faropenem medoxomil and clarithromycin in the Intent-to-Treat (safety) Population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    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 trial end is the time when the last subject has completed the follow-up visit or the follow-up SAE query contact has been completed. If a subject has a SAE, follow-up information for the SAE will be obtained until its outcome is established. If the trial is completed prior to information about the outcome of a SAE, the most up-to-date information prior to the end of the trial will be recorded
    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 months
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 131
    F.4.2.2In the whole clinical trial 770
    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)
    normal treatment of condition
    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 Decision2008-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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