Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Condition: Sinusitis; Bacterial Infections
MeSH terms: Bacterial Infections; Sinusitis
Intervention: Moxifloxacin (Avelox, BAY12-8039); Amoxicillin/Clavulanate
Intervention description: Patients will be administered daily a single moxifloxacin 400 mg tablet for 7 days; Patient will be administered daily Amoxicilline/Clavulanate 1000 mg tablets every 8 hours for 10 days
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of acute bacterial rhinosinusitis

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