Acute Bacterial Sinusitis (ABS)
Conditions
Brief summary
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
Interventions
DRUGClarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
DRUGAmoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The female must be non-lactating and at no risk for pregnancy. * Subject must have a diagnosis of ABS. The diagnosis must be based on the following: * A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or * Air/fluid levels purulent discharge from the nose * At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1. * A pre-treatment sample from a sinus puncture or * Middle meatus endoscopy must be obtained for bacterial aerobic culture * Susceptibility testing (applicable only for selected investigative sites). * Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.
Exclusion criteria
* A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics. * History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction. * Females who are pregnant or lactating. * Subject has either of the following: * Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1) * Significant anatomical abnormalities of the sinuses any other infection or * Condition which necessitates use of a concomitant systemic antibiotic. * Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied). * Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up. * Known significant renal or hepatic impairment (or disease). * Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration. * Immunocompromised subjects (e.g., neutropenic subjects). * Subjects with known HIV infection. * Treatment with any other investigational drug within 4 weeks prior to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response | 33 days |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Response | 33 days |
Countries
Canada, Greece, Hungary, Italy, Lithuania, Poland, Romania, Spain, United States
Outcome results
None listed