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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Sinusitis, Bacterial Infections

Intervention / Treatment
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* Drug: Moxifloxacin (Avelox, BAY12-8039)
* Drug: Amoxicillin/Clavulanate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin (Avelox, BAY12-8039)<br>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)<br>* Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days<br>|
| Active Comparator: Amoxicillin/Clavulanate<br>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<br>* Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Response (Intent-to-treat Population) | 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 | At 'Test-of-Cure', Day 1-3 after treatment | 
| 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 24-30 days after treatment was assessed by the investigator as continued clinical cure | End of Follow-up, Day 24-30 after treatment | 
| Number of Participants With Response (Microbiologically Valid Patients) | 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. | At 'Test-of-Cure', Day 1-3 after treatment | 
| Number of Participants With Response (Microbiologically Valid Patients) | 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. | End of Follow-up, Day 24-30 after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of acute bacterial rhinosinusitis