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

Abbott

Status and phase

Completed

Phase 4

Conditions

Acute Bacterial Sinusitis

Treatments

Drug: cefdinir (Omnicef)

Drug: levofloxacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00645073

M03-628

Details and patient eligibility

About

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.

Enrollment

271 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.