study of the safety and efficacy of cefdinir and levofloxacin for the treatment of subjects with acute bacterial sinusitis

Conditions: Acute Bacterial Sinusitis

Summary: to compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg qd, to a ten-day course of therapy of levofloxacin, 500 mg qd, in the treatment of acute bacterial sinusitis.


Eligibility criteria:
inclusion criteria: * a female must be non-lactating, non-breastfeeding and at no risk for pregnancy. * a condition of general good health, based upon the results of a medical history, physical examination, and laboratory profile. * subject must have a diagnosis of acute bacterial sinusitis. the diagnosis must be based on the following: * a sinus radiograph or ct scan performed within 48 hours pre-treatment * with evidence of maxillary opacification or air/fluid levels * purulent discharge from the nose * at least one of the following clinical signs and symptoms of acute bacterial sinusitis * lasting for more than 7 days prior to and no longer than 21 days before evaluation 1: facial pain over the sinus or facial pressure over the sinus or facial tightness over the sinus or facial swelling or toothache. * subject must be a suitable candidate for oral antimicrobial therapy and is able to swallow capsules intact. 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.

Keywords: acute bacterial sinusitis