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

Sponsored by:	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: Avelox (Moxifloxacin, BAY12-8039) Drug: Amoxicilline / clavulanate	Phase IV

MedlinePlus related topics: Bacterial Infections Sinusitis

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary objective will be the clinical response at the test of cure. [ Time Frame: Day 1-3 post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the microbiological efficacy of moxifloxacin and amoxicilline/clavulanate at TOC and FU in the microbiologically valid population (subgroup with positive baseline culture from middle meatus specimen) [ Time Frame: TOC day 1-3 post therapy and FU Day 24-30 post-therapy ] [ Designated as safety issue: No ]

Enrollment:	594
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
Arm 1: Experimental	Drug: Avelox (Moxifloxacin, BAY12-8039) Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days
Arm 2: Active Comparator	Drug: Amoxicilline / clavulanate Patient will be administered daily Amoxicilline/clavulanate 1000 mg tablets every 8 hours for 10 days

Detailed Description:

Number of arms: 2

(Group A: Moxifloxacin 400 mg tablets OD for 7 days and amoxicilline/clavulanate 1000 mg matching placebo tablets TID for 10 days; Group B: Amoxicilline/clavulanate 1000 mg tablets TID for 10 days and Moxifloxacin 400 mg matching placebo tablets OD for 7 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), HIV infection (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 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 expectance of less than 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493038

Locations

Italy

Siena, Italy, 53100

Roma, Italy, 00151

Pisa, Italy, 56126

Roma, Italy, 00184

Foggia, Italy, 71100

Bergamo, Italy, 24128

Lecce, Italy, 73100

Roma, Italy, 00135

Lecco, Italy, 23900

Matera, Italy, 75100

Catania, Italy, 95126

Treviso, Italy, 31100

Caserta, Italy, 81100

Pavia, Italy, 27100

Bari, Italy, 70123

Novara, Italy, 28100

Bolzano, Italy, 39100

Firenze, Italy, 50126

Milano, Italy, 20122

Catania, Italy, 95123

Perugia, Italy, 06126

Torino, Italy, 10141

Bologna, Italy, 40138

Torino, Italy, 10126

Milano, Italy, 20142

Benevento, Italy, 82100

Udine, Italy, 33100
Italy, Ascoli Piceno

San Benedetto del Tronto, Ascoli Piceno, Italy, 63039
Italy, Brescia

Esine, Brescia, Italy, 25040
Italy, Catanzaro

Lamezia Terme, Catanzaro, Italy, 88046
Italy, Forlì

Cesena, Forlì, Italy, 47023
Italy, Genova

Sestri Ponente, Genova, Italy, 16154
Italy, Milano

Monza, Milano, Italy, 20052
Italy, Ragusa

Comiso, Ragusa, Italy, 97013

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer S.p.A. ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	11881, EudraCT 2005-002779-34
Study First Received:	June 26, 2007
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00493038
Health Authority:	Italy: Ministry of Health

Keywords provided by Bayer:

Treatment of acute bacterial rhinosinusitis

Study placed in the following topic categories:

Bacterial Infections
Amoxicillin
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Moxifloxacin
Clavulanic Acid
Clavulanic Acids
Sinusitis
Amoxicillin-Potassium Clavulanate Combination

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Therapeutic Uses

Enzyme Inhibitors
Infection
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009