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.
