stop_circleTerminated/Withdrawn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
  • - 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

Trial summary

Enrollment Goal
293
Trial Dates
February 2006 - January 2008
Phase
Phase 4
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
A.O.U. SeneseSiena, 53100, Italy
Completed
A.O. San Camillo-ForlaniniRoma, 00151, Italy
Completed
ASL Vallecamonica-SebinoEsine, 25040, Italy
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
A.O.C.O. S.Giovanni AddolorataRoma, 00184, Italy
Completed
ASUR Marche ZT12 San BenedettoSan Benedetto del Tronto, 63039, Italy
Completed
A.O.U. Ospedali Riuniti FoggiaFoggia, 71100, Italy
Completed
A.O. Ospedali Riuniti BergamoBergamo, 24128, Italy
Completed
AUSL 7 Ragusa - SiciliaComiso, 97013, Italy
Completed
A.C.O. San Filippo NeriRoma, 00135, Italy
Completed
Azienda Sanitaria di BolzanoBolzano, 39100, Italy
Completed
ASL 6 Lamezia Terme - CalabriaLamezia Terme, 88046, Italy
Completed
AUSL 4 Matera - BasilicataMatera, 75100, Italy
Completed
AULSS 09 Treviso - VenetoTreviso, 31100, Italy
Completed
Università di PerugiaPerugia, 06122, Italy
Completed
A.S.O. San Luigi Gonzaga - Ospedale MartiniTorino, 10141, Italy
Completed
A.O. Gaetano RummoBenevento, 82100, Italy
Completed
AUSL Cesena - Emilia RomagnaCesena, 47023, Italy
Completed
AUSL Lecce - PugliaLecce, 73100, Italy
Completed
A.O. CannizzaroCatania, 95126, Italy
Completed
A.O. Sant'Anna-San SebastianoCaserta, 81100, Italy
Completed
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
ASL BA Bari - PugliaBari, 70123, Italy
Completed
A.O.U. Maggiore della CaritàNovara, 28100, Italy
Completed
A.O. Ospedale di LeccoLecco, 23900, Italy
Completed
AUSL 10 Firenze - ToscanaFirenze, 50126, Italy
Completed
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
ASL 3 Genovese - LiguriaSestri Ponente, 16154, Italy
Completed
A.O.U. PoliclinicoCatania, 95123, Italy
Completed
A.O. San Paolo Polo UniversitarioMilano, 20142, Italy
Completed
A.O.U. di Bologna - Policlinico S.Orsola-MalpighiBologna, 40138, Italy
Completed
A.O. Città della Salute e della Scienza di TorinoTorino, 10126, Italy
Completed
A.O.U. Santa Maria Misericordia UDUdine, 33100, Italy
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy

Primary Outcome

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

Secondary Outcome

  • Number of Participants With Response (Intent-to-treat Population)
    date_rangeTime Frame:
    At 'Test-of-Cure', Day 1-3 after treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of Participants With Response (Per-protocol Population)
    date_rangeTime Frame:
    End of Follow-up, Day 24-30 after treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of Participants With Response (Microbiologically Valid Patients)
    date_rangeTime Frame:
    At 'Test-of-Cure', Day 1-3 after treatment
    enhanced_encryption
    Safety Issue:
    No
  • Number of Participants With Response (Microbiologically Valid Patients)
    date_rangeTime Frame:
    End of Follow-up, Day 24-30 after treatment
    enhanced_encryption
    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
2

Additional Information

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