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

This study has been terminated.
(The study was prematurely terminated due to slow enrollment beyond the planned study timelines.)
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00493038
First received: June 26, 2007
Last updated: March 29, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Sinusitis
Bacterial Infections
Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Amoxicillin/Clavulanate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Participants With Response (Per-protocol Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ] [ Designated as safety issue: No ]
    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"


Secondary Outcome Measures:
  • Number of Participants With Response (Intent-to-treat Population) [ Time Frame: At 'Test-of-Cure', Day 1-3 after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 293
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
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
Drug: Amoxicillin/Clavulanate
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493038

Locations
Italy
San Benedetto del Tronto, Ascoli Piceno, Italy, 63039
Esine, Brescia, Italy, 25040
Lamezia Terme, Catanzaro, Italy, 88046
Cesena, Forlì, Italy, 47023
Sestri Ponente, Genova, Italy, 16154
Monza, Monza-Brianza, Italy, 20052
Comiso, Ragusa, Italy, 97013
Bari, Italy, 70123
Benevento, Italy, 82100
Bergamo, Italy, 24128
Bologna, Italy, 40138
Bolzano, Italy, 39100
Caserta, Italy, 81100
Catania, Italy, 95126
Catania, Italy, 95123
Firenze, Italy, 50126
Foggia, Italy, 71100
Lecce, Italy, 73100
Lecco, Italy, 23900
Matera, Italy, 75100
Milano, Italy, 20122
Milano, Italy, 20142
Novara, Italy, 28100
Pavia, Italy, 27100
Perugia, Italy, 06122
Pisa, Italy, 56126
Roma, Italy, 00184
Roma, Italy, 00135
Roma, Italy, 00151
Siena, Italy, 53100
Torino, Italy, 10141
Torino, Italy, 10126
Treviso, Italy, 31100
Udine, Italy, 33100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00493038     History of Changes
Other Study ID Numbers: 11881, 2005-002779-34
Study First Received: June 26, 2007
Results First Received: January 20, 2009
Last Updated: March 29, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Bayer:
Treatment of acute bacterial rhinosinusitis

Additional relevant MeSH terms:
Bacterial Infections
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014