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

Terminated/Withdrawn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
Status
LocationsStatus
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

A.O. San Camillo-Forlanini

Roma, Italy, 00151

Status
Completed
 
Locations

ASL Vallecamonica-Sebino

Esine, Italy, 25040

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

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

Roma, Italy, 00184

Status
Completed
 
Locations

ASUR Marche ZT12 San Benedetto

San Benedetto del Tronto, Italy, 63039

Status
Completed
 
Locations

A.O.U. Ospedali Riuniti Foggia

Foggia, Italy, 71100

Status
Completed
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Completed
 
Locations

AUSL 7 Ragusa - Sicilia

Comiso, Italy, 97013

Status
Completed
 
Locations

A.C.O. San Filippo Neri

Roma, Italy, 00135

Status
Completed
 
Locations

Azienda Sanitaria di Bolzano

Bolzano, Italy, 39100

Status
Completed
 
Locations

ASL 6 Lamezia Terme - Calabria

Lamezia Terme, Italy, 88046

Status
Completed
 
Locations

AUSL 4 Matera - Basilicata

Matera, Italy, 75100

Status
Completed
 
Locations

AULSS 09 Treviso - Veneto

Treviso, Italy, 31100

Status
Completed
 
Locations

Università di Perugia

Perugia, Italy, 06122

Status
Completed
 
Locations

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

Torino, Italy, 10141

Status
Completed
 
Locations

A.O. Gaetano Rummo

Benevento, Italy, 82100

Status
Completed
 
Locations

AUSL Cesena - Emilia Romagna

Cesena, Italy, 47023

Status
Completed
 
Locations

AUSL Lecce - Puglia

Lecce, Italy, 73100

Status
Completed
 
Locations

A.O. Cannizzaro

Catania, Italy, 95126

Status
Completed
 
Locations

A.O. Sant'Anna-San Sebastiano

Caserta, Italy, 81100

Status
Completed
 
Locations

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Status
Completed
 
Locations

ASL BA Bari - Puglia

Bari, Italy, 70123

Status
Completed
 
Locations

A.O.U. Maggiore della Carità

Novara, Italy, 28100

Status
Completed
 
Locations

A.O. Ospedale di Lecco

Lecco, Italy, 23900

Status
Completed
 
Locations

AUSL 10 Firenze - Toscana

Firenze, Italy, 50126

Status
Completed
 
Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
Locations

ASL 3 Genovese - Liguria

Sestri Ponente, Italy, 16154

Status
Completed
 
Locations

A.O.U. Policlinico

Catania, Italy, 95123

Status
Completed
 
Locations

A.O. San Paolo Polo Universitario

Milano, Italy, 20142

Status
Completed
 
Locations

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

Bologna, Italy, 40138

Status
Completed
 
Locations

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

Torino, Italy, 10126

Status
Completed
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Completed
 
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
 

Trial Design