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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: March 22, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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 Intervention Phase
Acute Bacterial Sinusitis Drug: cefdinir (Omnicef) Drug: levofloxacin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Abbott:

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

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

Enrollment: 271
Study Start Date: November 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00645073

  Show 33 Study Locations
Sponsors and Collaborators
  More Information

Responsible Party: Angela M Nilius, PhD, Abbott Identifier: NCT00645073     History of Changes
Other Study ID Numbers: M03-628
Study First Received: March 22, 2008
Last Updated: March 22, 2008

Keywords provided by Abbott:
Acute Bacterial Sinusitis

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal 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 processed this record on June 23, 2017