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Trial record 6 of 26 for:    "Sinusitis" | "Clavulanate"

Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT00493038
Recruitment Status : Terminated (The study was prematurely terminated due to slow enrollment beyond the planned study timelines.)
First Posted : June 27, 2007
Results First Posted : April 13, 2009
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE June 26, 2007
First Posted Date  ICMJE June 27, 2007
Results First Submitted Date  ICMJE January 20, 2009
Results First Posted Date  ICMJE April 13, 2009
Last Update Posted Date November 7, 2014
Study Start Date  ICMJE February 2006
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2011)
Number of Participants With Response (Per-protocol Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]
Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
To evaluate the microbiological response at the test of cure visit (specimen collected by the means of a microendoscope) [ Time Frame: TOC day 1-3 post therapy ]
Change History Complete list of historical versions of study NCT00493038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2011)
  • Number of Participants With Response (Intent-to-treat Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]
    Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as "clinical cure"
  • Number of Participants With Response (Per-protocol Population) [ Time Frame: End of Follow-up, Day 24-30 after treatment ]
    Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as "continued clinical cure"
  • Number of Participants With Response (Microbiologically Valid Patients) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ]
    Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
  • Number of Participants With Response (Microbiologically Valid Patients) [ Time Frame: End of Follow-up, Day 24-30 after treatment ]
    Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2007)
To evaluate the microbiological efficacy of moxifloxacin and amoxicilline/clavulanate at TOC and FU in the microbiologically valid population (subgroup with positive baseline culture from middle meatus specimen) [ Time Frame: TOC day 1-3 post therapy and FU Day 24-30 post-therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Official Title  ICMJE Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis
Brief Summary This is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in Italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sinusitis
  • Bacterial Infections
Intervention  ICMJE
  • Drug: Moxifloxacin (Avelox, BAY12-8039)
    Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
  • Drug: Amoxicillin/Clavulanate
    Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
Study Arms  ICMJE
  • Experimental: Moxifloxacin (Avelox, BAY12-8039)
    Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID)for 10 days
    Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
  • Active Comparator: Amoxicillin/Clavulanate
    Amoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
    Intervention: Drug: Amoxicillin/Clavulanate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 9, 2009)
293
Original Enrollment  ICMJE
 (submitted: June 26, 2007)
594
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >= 18 years
  • Clinical diagnosis of acute rhinosinusitis with signs and symptoms present for >/= 5-7 days but < 28 days
  • Clinical diagnosis will be confirmed by nasal endoscopic examination

Exclusion Criteria:

  • History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included)
  • Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
  • Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
  • Known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count < 1000/mm3), human immunodeficiency virus (HIV) infection (Cluster of differentiation 4 (CD4)+ T-cell count of < 200/mm3). Note: HIV testing is not required
  • Received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment
  • Requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol
  • Currently receiving topical nasal corticosteroids, unless they have been on a stable dose for > 4 weeks prior to enrollment
  • Requirement for concomitant therapy with systemic corticosteroids
  • Pregnant or breast feeding
  • Of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception
  • Received an investigational drug in the past 30 days
  • Previously enrolled in this study
  • Unable to take oral medication
  • History of allergy to quinolone antibiotics or related compounds and beta-lactams
  • History of tendinopathy associated with quinolones
  • Known to have congenital or sporadic syndromes of QT interval corrected for rate (QTc) prolongation or receiving concomitant medication reported to increase the QTc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine)
  • Uncorrected hypokalemia
  • End stage liver cirrhosis (class Child-Pugh C)
  • Severe renal impairment requiring dialysis
  • Diagnosis of rapidly fatal illness with a life expectancy of less than 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00493038
Other Study ID Numbers  ICMJE 11881
2005-002779-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP