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

Phase 4

Terminated

• Conditions: Sinusitis; Bacterial Infections
• Interventions: Drug: Amoxicillin/Clavulanate; Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT00493038
• Lead Sponsor: Bayer

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 available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-20
• Results First Submitted QC: 2009-03-09
• Results First Posted: 2009-04-13
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 293

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin/Clavulanate	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
Moxifloxacin (Avelox, BAY12-8039)	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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Response (Per-protocol Population)	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 Outcome Measures

Name	Time	Method
Number of Participants With Response (Intent-to-treat Population)	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)	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)	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.