Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis; Bacterial Infections
Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Amoxicillin/Clavulanate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Participants With Response (Per-protocol Population)
Secondary outcome: Number of Participants With Response (Intent-to-treat Population)Number of Participants With Response (Per-protocol Population) Number of Participants With Response (Microbiologically Valid Patients) Number of Participants With Response (Microbiologically Valid Patients)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bari 70123, Italy
Benevento 82100, Italy
Bergamo 24128, Italy
Bologna 40138, Italy
Bolzano 39100, Italy
Caserta 81100, Italy
Catania 95126, Italy
Catania 95123, Italy
Firenze 50126, Italy
Foggia 71100, Italy
Lecce 73100, Italy
Lecco 23900, Italy
Matera 75100, Italy
Milano 20142, Italy
Milano 20122, Italy
Novara 28100, Italy
Pavia 27100, Italy
Perugia 06122, Italy
Pisa 56126, Italy
Roma 00135, Italy
Roma 00151, Italy
Roma 00184, Italy
Siena 53100, Italy
Torino 10126, Italy
Torino 10141, Italy
Treviso 31100, Italy
Udine 33100, Italy
San Benedetto del Tronto, Ascoli Piceno 63039, Italy
Esine, Brescia 25040, Italy
Lamezia Terme, Catanzaro 88046, Italy
Cesena, Forlì 47023, Italy
Sestri Ponente, Genova 16154, Italy
Monza, Monza-Brianza 20052, Italy
Comiso, Ragusa 97013, Italy
Additional Information
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Starting date: February 2006
Last updated: November 3, 2014
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