Terminated/Withdrawn

Sinusitis, Bacterial Infections

Bayer Identifier:

11881

ClinicalTrials.gov Identifier:

NCT00493038

EudraCT Number:

2005-002779-34

EU CT Number:

Not Available

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

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

Key Participants Requirements

Sex

Both

Age

18 Years

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

February 2006 - January 2008

Phase

Phase 4

Could I Receive a placebo

Products

Avelox (Moxifloxacin hydrochloride, BAY12-8039)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	A.O.U. Senese	Siena, 53100, Italy
Completed	A.O. San Camillo-Forlanini	Roma, 00151, Italy
Completed	ASL Vallecamonica-Sebino	Esine, 25040, Italy
Completed	A.O.U. Pisana	Pisa, 56126, Italy
Completed	A.O.C.O. S.Giovanni Addolorata	Roma, 00184, Italy
Completed	ASUR Marche ZT12 San Benedetto	San Benedetto del Tronto, 63039, Italy
Completed	A.O.U. Ospedali Riuniti Foggia	Foggia, 71100, Italy
Completed	A.O. Ospedali Riuniti Bergamo	Bergamo, 24128, Italy
Completed	AUSL 7 Ragusa - Sicilia	Comiso, 97013, Italy
Completed	A.C.O. San Filippo Neri	Roma, 00135, Italy
Completed	Azienda Sanitaria di Bolzano	Bolzano, 39100, Italy
Completed	ASL 6 Lamezia Terme - Calabria	Lamezia Terme, 88046, Italy
Completed	AUSL 4 Matera - Basilicata	Matera, 75100, Italy
Completed	AULSS 09 Treviso - Veneto	Treviso, 31100, Italy
Completed	Università di Perugia	Perugia, 06122, Italy
Completed	A.S.O. San Luigi Gonzaga - Ospedale Martini	Torino, 10141, Italy
Completed	A.O. Gaetano Rummo	Benevento, 82100, Italy
Completed	AUSL Cesena - Emilia Romagna	Cesena, 47023, Italy
Completed	AUSL Lecce - Puglia	Lecce, 73100, Italy
Completed	A.O. Cannizzaro	Catania, 95126, Italy
Completed	A.O. Sant'Anna-San Sebastiano	Caserta, 81100, Italy
Completed	IRCCS Policlinico San Matteo	Pavia, 27100, Italy
Completed	ASL BA Bari - Puglia	Bari, 70123, Italy
Completed	A.O.U. Maggiore della Carità	Novara, 28100, Italy
Completed	A.O. Ospedale di Lecco	Lecco, 23900, Italy
Completed	AUSL 10 Firenze - Toscana	Firenze, 50126, Italy
Completed	IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milano, 20122, Italy
Completed	ASL 3 Genovese - Liguria	Sestri Ponente, 16154, Italy
Completed	A.O.U. Policlinico	Catania, 95123, Italy
Completed	A.O. San Paolo Polo Universitario	Milano, 20142, Italy
Completed	A.O.U. di Bologna - Policlinico S.Orsola-Malpighi	Bologna, 40138, Italy
Completed	A.O. Città della Salute e della Scienza di Torino	Torino, 10126, Italy
Completed	A.O.U. Santa Maria Misericordia UD	Udine, 33100, Italy
Completed	A.O. San Gerardo di Monza	Monza, 20052, Italy

Primary Outcome

Number of Participants With Response (Per-protocol Population)
Time Frame:
At 'Test-of-Cure', Day 1-3 after treatment
Safety Issue:
No

Secondary Outcome

Number of Participants With Response (Intent-to-treat Population)
Time Frame:
At 'Test-of-Cure', Day 1-3 after treatment
Safety Issue:
No
Number of Participants With Response (Per-protocol Population)
Time Frame:
End of Follow-up, Day 24-30 after treatment
Safety Issue:
No
Number of Participants With Response (Microbiologically Valid Patients)
Time Frame:
At 'Test-of-Cure', Day 1-3 after treatment
Safety Issue:
No
Number of Participants With Response (Microbiologically Valid Patients)
Time Frame:
End of Follow-up, Day 24-30 after treatment
Safety Issue:
No

Trial design

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

Additional Information

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