Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Bacterial Sinusitis
Intervention: cefdinir (Omnicef) (Drug); levofloxacin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Abbott
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.
Clinical Details
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
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinical cure rate
Secondary outcome: Radiographic responseChanges from baseline in clinical signs and symptoms
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Gorzow Wielkopolski 66-400, Poland
Krakow 30-510, Poland
Krakow 31-513, Poland
Lodz 90-430, Poland
Lodz 92-215, Poland
Przybyslawice 322-088, Poland
Skierniewice 96-100, Poland
Szczecin 70-344, Poland
Szczecin 70-506, Poland
Szczecin 71-667, Poland
Birmingham, Alabama 35215, United States
Birmingham, Alabama 35211, United States
Columbiana, Alabama 35051, United States
Eclectic, Alabama 36024, United States
Tuscaloosa, Alabama 35406, United States
Mesa, Arizona 85201, United States
Fresno, California 93710, United States
Fresno, California 93703, United States
Murray, Kentucky 42071, United States
Portage, Michigan 49024, United States
Eugene, Oregon 97404, United States
Lake Oswego, Oregon 97035, United States
Orangeburg, South Carolina 29118, United States
Kingsport, Tennessee 37660, United States
Milan, Tennessee 38358, United States
Corsicana, Texas 75110, United States
San Antonio, Texas 78205, United States
Salt Lake City, Utah 84109, United States
Salt Lake City, Utah 84121, United States
West Jordan, Utah 84084, United States
West Jordan, Utah 84088, United States
Winchester, Virginia 22601, United States
Spokane, Washington 99204, United States
Additional Information
Starting date: November 2003
Last updated: March 22, 2008
|