Trial Condition(s):

Sinusitis, Bacterial Infections

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

Bayer Identifier:

11881

ClinicalTrials.gov Identifier:

NCT00493038

EudraCT Number:

2005-002779-34

EU CT Number:

Not Available

Terminated/Withdrawn

Trial 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

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

Trial Summary

Enrollment Goal
293
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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A.O.U. Senese

Siena, Italy, 53100

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A.O. San Camillo-Forlanini

Roma, Italy, 00151

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ASL Vallecamonica-Sebino

Esine, Italy, 25040

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A.O.U. Pisana

Pisa, Italy, 56126

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A.O.C.O. S.Giovanni Addolorata

Roma, Italy, 00184

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ASUR Marche ZT12 San Benedetto

San Benedetto del Tronto, Italy, 63039

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A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

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A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

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AUSL 7 Ragusa - Sicilia

Comiso, Italy, 97013

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A.C.O. San Filippo Neri

Roma, Italy, 00135

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Azienda Sanitaria di Bolzano

Bolzano, Italy, 39100

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ASL 6 Lamezia Terme - Calabria

Lamezia Terme, Italy, 88046

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AUSL 4 Matera - Basilicata

Matera, Italy, 75100

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AULSS 09 Treviso - Veneto

Treviso, Italy, 31100

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Università di Perugia

Perugia, Italy, 06122

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A.S.O. San Luigi Gonzaga - Ospedale Martini

Torino, Italy, 10141

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A.O. Gaetano Rummo

Benevento, Italy, 82100

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AUSL Cesena - Emilia Romagna

Cesena, Italy, 47023

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AUSL Lecce - Puglia

Lecce, Italy, 73100

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A.O. Cannizzaro

Catania, Italy, 95126

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A.O. Sant'Anna-San Sebastiano

Caserta, Italy, 81100

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IRCCS Policlinico San Matteo

Pavia, Italy, 27100

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ASL BA Bari - Puglia

Bari, Italy, 70123

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A.O.U. Maggiore della Carità

Novara, Italy, 28100

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A.O. Ospedale di Lecco

Lecco, Italy, 23900

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AUSL 10 Firenze - Toscana

Firenze, Italy, 50126

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IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

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ASL 3 Genovese - Liguria

Sestri Ponente, Italy, 16154

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A.O.U. Policlinico

Catania, Italy, 95123

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A.O. San Paolo Polo Universitario

Milano, Italy, 20142

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A.O.U. di Bologna - Policlinico S.Orsola-Malpighi

Bologna, Italy, 40138

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A.O. Città della Salute e della Scienza di Torino

Torino, Italy, 10126

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A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

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A.O. San Gerardo di Monza

Monza, Italy, 20052

Trial Design