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
Overview
- Phase
- Phase 4
- Intervention
- Moxifloxacin (Avelox, BAY12-8039)
- Conditions
- Sinusitis
- Sponsor
- Bayer
- Enrollment
- 293
- Primary Endpoint
- Number of Participants With Response (Per-protocol Population)
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
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
Investigators
Eligibility 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
Arms & Interventions
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: Moxifloxacin (Avelox, BAY12-8039)
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: Amoxicillin/Clavulanate
Outcomes
Primary Outcomes
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"
Secondary Outcomes
- 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)(End of Follow-up, Day 24-30 after treatment)