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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645073
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Acute Bacterial Sinusitis Drug: cefdinir (Omnicef) Drug: levofloxacin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 271 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2003
Actual Primary Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Active Comparator: A Drug: cefdinir (Omnicef)
Two 300 mg cefdinir capsules on Study Days 1-10.
Other Names:
  • ABT-198
  • Omnicef
  • cefdinir

Active Comparator: B Drug: levofloxacin
Two 250 mg levofloxacin capsules on Study Days 1-10

Primary Outcome Measures :
  1. Clinical cure rate [ Time Frame: 26 days ]

Secondary Outcome Measures :
  1. Radiographic response [ Time Frame: 26 days ]
  2. Changes from baseline in clinical signs and symptoms [ Time Frame: 26 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645073

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United States, Alabama
Birmingham, Alabama, United States, 35211
Birmingham, Alabama, United States, 35215
Columbiana, Alabama, United States, 35051
Eclectic, Alabama, United States, 36024
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Mesa, Arizona, United States, 85201
United States, California
Fresno, California, United States, 93703
Fresno, California, United States, 93710
United States, Kentucky
Murray, Kentucky, United States, 42071
United States, Michigan
Portage, Michigan, United States, 49024
United States, Oregon
Eugene, Oregon, United States, 97404
Lake Oswego, Oregon, United States, 97035
United States, South Carolina
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Kingsport, Tennessee, United States, 37660
Milan, Tennessee, United States, 38358
United States, Texas
Corsicana, Texas, United States, 75110
San Antonio, Texas, United States, 78205
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
West Jordan, Utah, United States, 84084
West Jordan, Utah, United States, 84088
United States, Virginia
Winchester, Virginia, United States, 22601
United States, Washington
Spokane, Washington, United States, 99204
Gorzow Wielkopolski, Poland, 66-400
Krakow, Poland, 30-510
Krakow, Poland, 31-513
Lodz, Poland, 90-430
Lodz, Poland, 92-215
Przybyslawice, Poland, 322-088
Skierniewice, Poland, 96-100
Szczecin, Poland, 70-344
Szczecin, Poland, 70-506
Szczecin, Poland, 71-667
Sponsors and Collaborators
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Responsible Party: Angela M Nilius, PhD, Abbott Identifier: NCT00645073    
Other Study ID Numbers: M03-628
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008
Keywords provided by Abbott:
Acute Bacterial Sinusitis
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors