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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00493038

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 IV

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:

MedlinePlus related topics: Bacterial Infections Sinusitis

Drug Information available for: Amoxicillin Amoxicillin sodium Clavulanic acid Amoxicillin trihydrate Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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

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, 16153

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, 50125

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, 06126

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:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer S.p.A.
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:	November 25, 2011
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
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012