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    Summary
    EudraCT Number:2011-002955-33
    Sponsor's Protocol Code Number:027SC10363
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-04
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2011-002955-33
    A.3Full title of the trial
    Clinical and microbiological assessment of prulifloxacin in patients with Acute Bacterial Rhinosinusitis (ABRS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prulifloxacin in ABRS
    A.3.2Name or abbreviated title of the trial where available
    Prulifloxacin in ABRS
    A.4.1Sponsor's protocol code number027SC10363
    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 SponsorAziende Chimiche Riunite Angelini Francesco S.p.A
    B.1.3.4CountryItaly
    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 supportAziende Chimiche Riunite Angelini Francesco S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Siena
    B.5.2Functional name of contact pointDesiderio Passali
    B.5.3 Address:
    B.5.3.1Street Addressvia Banchi di Sotto
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number0039577585470
    B.5.5Fax number003957747940
    B.5.6E-maild.passali@virgilio.it
    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 Unidrox
    D.2.1.1.2Name of the Marketing Authorisation holderAziende Chimiche Riunite Angelini Franceso S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameUnidrox
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNPRULIFLOXACIN
    D.3.9.1CAS number 123447-62-1
    D.3.9.4EV Substance CodeSUB10156MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male or female adults with ABRS, defined as the presence of 2 (including at least one between nasal blockage/congestion/ obstruction or nasal discharge) or more of the following signs and symptoms: nasal blockage/congestion/obstruction; nasal discharge (anterior/post nasal drip); facial pain/pressure; reduction/loss of smell. Persistent symptoms for 10 days or an increase of symptoms after 5 days, and with a duration lower then 12 weeks.
    E.1.1.1Medical condition in easily understood language
    Patients with Acute Bacterial Rhinosinusitis (ABRS).
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate at the Test Of Cure (TOC) visit, the clinical efficacy of prulifloxacin in the treatment of patients with ABRS.
    E.2.2Secondary objectives of the trial
    i) To evaluate the microbiological efficacy of prulifloxacin in eradicating bacterial pathogens at the TOC visit;
    ii) To compare the clinical and microbiological outcomes;
    iii) To compare the results of cultures obtained at the Screening visit by Endoscopically Directed Middle Meatal (EDMM) sampling with those obtained by maxillary sinus tap (MST) through the canine fossa;
    iv) To assess at the (LPT) visit the clinical efficacy of prulifloxacin;
    v) To evaluate the safety and tolerability of the investigational drug.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female adults (age > 18 years) with no limitation of race using an appropriate birth control method.
    2. Patients with Acute Bacterial Rhinosinusitis (ABRS) defined as a superinfection of a pre-existing Acute Viral Rhinosinusitis characterized by persistent symptoms for 10 days or an increase of symptoms after 5 days, and with a duration lower than 12 weeks
    3. Clinical diagnosis of ABRS defined as the presence of two (including at least one between nasal blockage/congestion/obstruction or nasal discharge) or more of the following signs and symptoms
    - nasal blockage/congestion/obstruction,
    - nasal discharge: anterior/post nasal drip,
    - facial pain/pressure,
    - reduction/loss of smell.
    4.Clinical diagnosis of moderate/severe ABRS
    5.Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent prior to the inclusion in the study.
    E.4Principal exclusion criteria
    1.Known hypersensitivity or allergy to prulifloxacin or other fluoroquinolone antibacterials and/or to any component of the prulifloxacin tablet.
    2. Known hypersensitivity or allergy to substances used for topical or intravenous anesthesia/sedation (only for patients requiring anesthesia/sedation related to diagnostic procedures)
    3. Nosocomial sinus infection or infections following or associated with naso-tracheal intubation.
    4. Chronic rhinosinusitis (duration of symptoms for more than 12 weeks) or complicated rhinosinusitis (brain abscess or venous trombosis).
    5. Nasal polyps. The absence of nasal polyps should be endoscopically confirmed.
    6. Patients with nasal anatomic abnormalities (i.e., septum deviation) that not allowed or impaired the middle meatus visualization and/or sampling.
    7. History of sinus surgery.
    8. History of tendinopathy associated with use of fluoroquinolones.
    9. Childbearing potential where pregnancy is not excluded by pregnancy test in urine (β-HCG), or lactation.
    10. Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
    11. Known severe liver and/or renal insufficiency (AST, ALT, γ-GT and/or creatinine levels more than twice as high as the Upper Laboratory Norm).
    12.Immunosuppressed patients or patients with cystic fibrosis.
    13. Concurrent infections and/or neoplasm.
    14. Concomitant treatment with hypoglycemic drugs.
    15. Concomitant treatment with xanthines.
    16. Treatment with antibiotics or antibacterials within the previous week.
    17. Treatment with experimental drugs in the previous 4 weeks.
    18. Positive history for drugs and alcohol abuse. Patients who had an alcohol or drugs abuse within 24 h before the enrollment in the present study will be also excluded.
    19. Inability to comply with the protocol requirements, instructions and study-related restrictions (i.e., uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study).
    20. Vulnerable subjects (i.e., persons kept in detention).
    21. The patient is the Investigator or his/her deputies, first grade relatives, assistant, pharmacist, or other personnel directly involved in the study conduct.
    22. Participation to an interventional clinical trial within 3 months prior to the Screening visit prior to the inclusion in the study.
    E.5 End points
    E.5.1Primary end point(s)
    At each visit, the following signs and symptoms will be graded according to a 4-point scale (0=absent, 1=mild, 2=moderate, 3=severe): nasal blockage/obstruction/congestion, nasal discharge (anterior/post nasal drip), facial pain/pressure, reduction/loss of smell.
    A sign or symptom is considered resolved when it is present (graded as one, two or three) pre-treatment, but becomes absent (graded as zero) at the TOC. A sign or symptom is considered worsened when its grading at the TOC visit is greater than its grading pre-treatment.The primary parameter for clinical efficacy will be the comparison of symptoms and signs scores reported at the TOC visit with those reported at the Screening.At the TOC visit, the following definitions will be used [Henry 2004]:
    Cure: resolution of at least 1 of the acute pre-treatment signs and symptoms (as above reported), with no worsening in the remaining signs and symptoms.
    Failure: no resolution of acute pre-treatment signs and symptoms (as above reported), or worsening at least 1 of the acute pre-treatment signs and symptoms, or treatment before the TOC visit with additional antibiotic therapy for ABRS.
    Indeterminate: presence of extenuating circumstances that precluded evaluation of the clinical response.
    Clinical success will be defined as cure. Indeterminate results will be considered as not evaluable for statistical purposes and will be excluded from the analysis. Patients with clinical failure at Visit 2 (Intermediate) or Visit 3 (TOC) will be treated with adequate therapy, and will not be followed-up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 3 (TOC) visit
    E.5.2Secondary end point(s)
    Microbiological efficacy.
    At the Screening, microbiological assessment will be carried out on samples collected by EDMM, in a subset of patients,by MST,while at the TOC visit only sampling by EDMM will be performed.
    Results obtained at the TOC visit will be compared with those obtained at the Screening. Sampling with EDMM will represent the main reference test.
    Bacteriological response will be defined according to the following definitions:

    Eradication: the original causative organism detected at screening (by EDMM and/or MST sampling) is absent in in the secretions culture at the TOC visit.
    Presumed eradication: absence of appropriate culture material by EDMM at the TOC visit (i.e., no secretions from the middle meatus are available), in presence of clinical cure.
    Presumed persistence: absence of appropriate culture material by EDMM at the TOC visit (i.e., no secretions from the middle meatus are available), in presence of clinical failure.
    Persistence: the causative organism detected at screening is still present in the secretions culture at the TOC visit (the identity of the organisms isolates at the two visits should be confirmed by phenotypic and genotypic methods).
    Superinfection/New colonization: a new pathogen is detected from the secretions culture at the TOC visit.
    Indeterminate: bacteriological response not evaluable for any other reason.
    Bacteriological success will be defined as eradication or presumed eradication. Bacteriological failure will be defined as persistence or superinfection/new colonization or presumed persistence.
    Indeterminate results will be considered as not evaluable for statistical purposes and will be excluded from the analysis.
    The consistency and correlation of microbiological results obtained at Screening through EDMM and puncture of the maxillary sinus will be also assessed.



    Clinical and microbiological outcome
    The correlation in the individual clinical and microbiological results obtained at the TOC visit will be assessed.The following definitions will be used.
    Patients with clinical cure at the TOC visit and with a negative culture will be defined as “patient clinically cured with confirmed microbiological eradication”.
    Patients with clinical cure at the TOC visit and without of appropriate culture material will be defined as “patient clinically cured with presumed microbiological eradication”.
    Patients with clinical cure at the TOC visit but with a positive culture showing the causative organism will be defined as “patient clinically cured with microbiological persistence”.
    Patients with clinical cure at the TOC visit but with a positive culture showing a new pathogen will be defined as “patient clinically cured with microbiological colonization”.
    Patients with clinical failure at the TOC visit and with a positive culture showing the causative organism will be defined as “patient with clinical failure and a microbiologically confirmed persistence”.
    Patients with clinical failure at the TOC visit and with a positive culture showing a new pathogen will be defined as “patient with clinical failure and a microbiologically confirmed superinfection”.
    Patients with clinical failure at the TOC visit and without an appropriate culture material will be defined as “patient with clinical failure and presumed microbiological persistence”.
    Patients with clinical failure at the TOC visit and with a negative culture will be defined as “patient with non-microbiologically confirmed clinical failure”.


    Clinical efficacy at LPT
    The prulifloxacin clinical efficacy at the LPT follow-up will be evaluated in patients cured at Visit 3 (TOC). In these patients, scores obtained at the LPT Visit will be compared with those obtained at the TOC visit.
    The following definitions will be used:
    Sustained cure: no change, or improvement or resolution of signs and symptoms reported at the TOC visit, and no occurrence of new signs or symptoms.
    Late post-therapy failure: worsening of at least 1 of signs and symptoms reported at the TOC visit, or the appearance of at least 1 new sign or symptom, or treatment after Visit 3 (TOC) with additional antibiotic therapy for ABRS symptoms.
    Indeterminate: presence of extenuating circumstances that precluded evaluation of the clinical response. Indeterminate results will be considered as not evaluable for statistical purposes and will be excluded from the analysis.
    The consistency and correlation of microbiological results obtained at Screening through EDMM and puncture of the maxillary sinus will be also assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Visit 3 (TOC), Visit 4 (LPT)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 end of the trial will be the date of the last visit of the last patient or the completion of any follow-up procedure described in the protocol.
    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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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 Decision2012-02-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-10
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