Trial Condition(s):
Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
11881
Not Available
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
- 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
- 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
Locations | Status | |
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Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00151 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL Vallecamonica-Sebino Esine, Italy, 25040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.C.O. S.Giovanni Addolorata Roma, Italy, 00184 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASUR Marche ZT12 San Benedetto San Benedetto del Tronto, Italy, 63039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Ospedali Riuniti Foggia Foggia, Italy, 71100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 7 Ragusa - Sicilia Comiso, Italy, 97013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.C.O. San Filippo Neri Roma, Italy, 00135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Azienda Sanitaria di Bolzano Bolzano, Italy, 39100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL 6 Lamezia Terme - Calabria Lamezia Terme, Italy, 88046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 4 Matera - Basilicata Matera, Italy, 75100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AULSS 09 Treviso - Veneto Treviso, Italy, 31100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Perugia Perugia, Italy, 06122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.S.O. San Luigi Gonzaga - Ospedale Martini Torino, Italy, 10141 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Gaetano Rummo Benevento, Italy, 82100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Cesena - Emilia Romagna Cesena, Italy, 47023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL Lecce - Puglia Lecce, Italy, 73100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Cannizzaro Catania, Italy, 95126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Sant'Anna-San Sebastiano Caserta, Italy, 81100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL BA Bari - Puglia Bari, Italy, 70123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Maggiore della Carità Novara, Italy, 28100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedale di Lecco Lecco, Italy, 23900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 10 Firenze - Toscana Firenze, Italy, 50126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ASL 3 Genovese - Liguria Sestri Ponente, Italy, 16154 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Policlinico Catania, Italy, 95123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Paolo Polo Universitario Milano, Italy, 20142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Bologna - Policlinico S.Orsola-Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Città della Salute e della Scienza di Torino Torino, Italy, 10126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Santa Maria Misericordia UD Udine, Italy, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2