Acute Bacterial Sinusitis
Conditions
Keywords
Acute Bacterial Sinusitis
Brief 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.
Interventions
Two 300 mg cefdinir capsules on Study Days 1-10.
DRUGlevofloxacin
Two 250 mg levofloxacin capsules on Study Days 1-10
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate | 26 days |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic response | 26 days |
| Changes from baseline in clinical signs and symptoms | 26 days |
Countries
Poland, United States
Outcome results
None listed