Clinical trial NCT00493038: Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sinusitis
Bacterial Infections
Keywords: Treatment of acute bacterial rhinosinusitis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Response (Per-protocol Population)
timeFrame: At 'Test-of-Cure', Day 1-3 after treatment
Secondary outcomes:
measure: Number of Participants With Response (Intent-to-treat Population)
timeFrame: At 'Test-of-Cure', Day 1-3 after treatment
measure: Number of Participants With Response (Per-protocol Population)
timeFrame: End of Follow-up, Day 24-30 after treatment
measure: Number of Participants With Response (Microbiologically Valid Patients)
timeFrame: At 'Test-of-Cure', Day 1-3 after treatment
measure: Number of Participants With Response (Microbiologically Valid Patients)
timeFrame: End of Follow-up, Day 24-30 after treatment
Other outcomes:
Locations:
city: San Benedetto del Tronto
country: Italy
state: Ascoli Piceno
city: Esine
country: Italy
state: Brescia
city: Lamezia Terme
country: Italy
state: Catanzaro
city: Cesena
country: Italy
state: Forlì
city: Sestri Ponente
country: Italy
state: Genova
city: Monza
country: Italy
state: Monza-Brianza
city: Comiso
country: Italy
state: Ragusa
city: Bari
country: Italy
city: Benevento
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Bolzano
country: Italy
city: Caserta
country: Italy
city: Catania
country: Italy
city: Catania
country: Italy
city: Firenze
country: Italy
city: Foggia
country: Italy
city: Lecce
country: Italy
city: Lecco
country: Italy
city: Matera
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Novara
country: Italy
city: Pavia
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Siena
country: Italy
city: Torino
country: Italy
city: Torino
country: Italy
city: Treviso
country: Italy
city: Udine
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: