Study to Evaluate the Efficacy and Safety of Moxifloxacin Versus Amoxicillin/Clavulanate in the Treatment of Acute Bacterial Rhinosinusitis
Information source: Bayer
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sinusitis; Bacterial Infections
Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Manager, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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 Rhinosinusitis
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Primary outcome: To evaluate the microbiological response at the test of cure visit (specimen collected by the means of a microendoscope)
Secondary outcome: To evaluate the microbiological efficacy of moxifloxacin and amoxicillin/clavulanate at TOC and FU in the microbiologically valid population (subgroup with positive baseline culture from middle meatus specimen)
Detailed description:
Number of arms: 2
(Group A: Moxifloxacin 400 mg tablets OD for 7 days and amoxicillin/clavulanate 1000 mg
matching placebo tablets TID for 10 days; Group B: Amoxicillin/clavulanate 1000 mg tablets
TID for 10 days and Moxifloxacin 400 mg matching placebo tablets OD for 7 days.)
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), HIV infection (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 a 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 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
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Bayer Clinical Research Center, ask Contact, Italy; Recruiting
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product
Starting date: February 2006
Last updated: August 14, 2007
|
