Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis

Exclusion Criteria

• •Subjects who have: chronic sinusitis (signs and symptoms lasting greater than 28 days prior to Evaluation 1)
• •Significant anatomical abnormalities of the sinuses
• •Any other infection or condition which necessitates use of a concomitant systemic antimicrobial.
• •History of any hypersensitivity or allergic reactions to penicillins, cephalosporins (including cefdinir), or quinolones (including levofloxacin).
• •Subject who has taken: a systemic antibiotic within 14 days before study drug administration; a long acting injectable antibiotic (e.g., penicillin G benzathine) within 30 days before study drug administration.
• •Known significant renal or hepatic impairment.
• •Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
• •Investigator considers the subject unsuitable for cefdinir or levofloxacin therapy, for any reason.
• •Previous enrollment in this study.
• •Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluations or absorption of study drug.
• •Subject who is currently receiving or who is likely to require any of the following medications during the period between Evaluation 1 (initial presentation to office/clinic) and Evaluation 3 (or within 48 hours after the last dose of study drug): Concomitant theophylline or any theophylline analog, unless plasma levels of these drugs can be adequately monitored during the study; Warfarin and probenecid.
• •Immunocompromised subjects.
• •Subject who requires parenteral antibiotic therapy for this infection or who has any other infection or condition, that necessitates use of a concomitant systemic antibiotic.
• •Subjects receiving antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc within 2 hours before or after dosing with study drug.
• •Subjects with a known or suspected central nervous system disorder that may predispose the subject to seizures or lower the seizure threshold.