Study Stopped
The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
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
2 other identifiers
interventional
293
1 country
34
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2006
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 26, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedResults Posted
Study results publicly available
April 13, 2009
CompletedNovember 7, 2014
November 1, 2014
1.9 years
June 26, 2007
January 20, 2009
November 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Response (Per-protocol Population)
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"
At 'Test-of-Cure', Day 1-3 after treatment
Secondary Outcomes (4)
Number of Participants With Response (Intent-to-treat Population)
At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Per-protocol Population)
End of Follow-up, Day 24-30 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
At 'Test-of-Cure', Day 1-3 after treatment
Number of Participants With Response (Microbiologically Valid Patients)
End of Follow-up, Day 24-30 after treatment
Study Arms (2)
Moxifloxacin (Avelox, BAY12-8039)
EXPERIMENTALMoxifloxacin (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
Amoxicillin/Clavulanate
ACTIVE COMPARATORAmoxicillin/clavulanate 1000 mg tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
Interventions
Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (34)
Unknown Facility
San Benedetto del Tronto, Ascoli Piceno, 63039, Italy
Unknown Facility
Esine, Brescia, 25040, Italy
Unknown Facility
Lamezia Terme, Catanzaro, 88046, Italy
Unknown Facility
Cesena, Forlì, 47023, Italy
Unknown Facility
Sestri Ponente, Genova, 16154, Italy
Unknown Facility
Monza, Monza-Brianza, 20052, Italy
Unknown Facility
Comiso, Ragusa, 97013, Italy
Unknown Facility
Bari, 70123, Italy
Unknown Facility
Benevento, 82100, Italy
Unknown Facility
Bergamo, 24128, Italy
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Bolzano, 39100, Italy
Unknown Facility
Caserta, 81100, Italy
Unknown Facility
Catania, 95123, Italy
Unknown Facility
Catania, 95126, Italy
Unknown Facility
Florence, 50126, Italy
Unknown Facility
Foggia, 71100, Italy
Unknown Facility
Lecce, 73100, Italy
Unknown Facility
Lecco, 23900, Italy
Unknown Facility
Matera, 75100, Italy
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Milan, 20142, Italy
Unknown Facility
Novara, 28100, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Perugia, 06122, Italy
Unknown Facility
Pisa, 56126, Italy
Unknown Facility
Roma, 00135, Italy
Unknown Facility
Roma, 00151, Italy
Unknown Facility
Roma, 00184, Italy
Unknown Facility
Siena, 53100, Italy
Unknown Facility
Torino, 10126, Italy
Unknown Facility
Torino, 10141, Italy
Unknown Facility
Treviso, 31100, Italy
Unknown Facility
Udine, 33100, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was prematurely terminated due to slow enrollment beyond the planned study timelines.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2007
First Posted
June 27, 2007
Study Start
February 1, 2006
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
November 7, 2014
Results First Posted
April 13, 2009
Record last verified: 2014-11