Official Title: “A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: cefdinir (Omnicef)
  • Two 300 mg cefdinir capsules on Study Days 1-10.
• Drug: levofloxacin
  • Two 250 mg levofloxacin capsules on Study Days 1-10

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
• Active Comparator: B

Primary Measures

• Clinical cure rate
  • Time Frame: 26 days
    Safety Issue?: No

Secondary Measures

• Radiographic response
  • Time Frame: 26 days
    Safety Issue?: No
• Changes from baseline in clinical signs and symptoms
  • Time Frame: 26 days
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645073

Study ID Number: M03-628

ClinicalTrials.gov Identifier: NCT00645073

Health Authority: United States: Food and Drug Administration