Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

- 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.

- 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.