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

A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Bacterial Sinusitis
• Intervention / Treatment: Drug: cefdinir (Omnicef); Drug: levofloxacin

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Gorzow Wielkopolski, Poland, 66-400
  • Krakow, Poland, 30-510
  • Krakow, Poland, 31-513
  • Lodz, Poland, 92-215
  • Lodz, Poland, 90-430
  • Przybyslawice, Poland, 322-088
  • Skierniewice, Poland, 96-100
  • Szczecin, Poland, 70-344
  • Szczecin, Poland, 70-506
  • Szczecin, Poland, 71-667
• 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
  • Arizona
    • Mesa, Arizona, United States, 85201
  • California
    • Fresno, California, United States, 93710
    • Fresno, California, United States, 93703
  • Kentucky
    • Murray, Kentucky, United States, 42071
  • Michigan
    • Portage, Michigan, United States, 49024
  • Oregon
    • Eugene, Oregon, United States, 97404
    • Lake Oswego, Oregon, United States, 97035
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
    • Milan, Tennessee, United States, 38358
  • Texas
    • Corsicana, Texas, United States, 75110
    • San Antonio, Texas, United States, 78205
  • Utah
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84109
    • West Jordan, Utah, United States, 84088
    • West Jordan, Utah, United States, 84084
  • Virginia
    • Winchester, Virginia, United States, 22601
  • Washington
    • Spokane, Washington, United States, 99204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinical cure rate	26 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic response	26 days
Changes from baseline in clinical signs and symptoms	26 days

Collaborators and Investigators

• Sponsor: Abbott

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (Actual): March 1, 2004

Study Registration Dates

• First Submitted: March 22, 2008
• First Submitted That Met QC Criteria: March 22, 2008
• First Posted (Estimate): March 27, 2008

Study Record Updates

• Last Update Posted (Estimate): March 27, 2008
• Last Update Submitted That Met QC Criteria: March 22, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Acute Bacterial Sinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin; Cefdinir
• Other Study ID Numbers: M03-628