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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.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00645073
First received: March 22, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic response [ Time Frame: 26 days ] [ Designated as safety issue: No ]
  • Changes from baseline in clinical signs and symptoms [ Time Frame: 26 days ] [ Designated as safety issue: No ]

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
Other Name: levofloxacin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645073

  Show 33 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Angela M Nilius, PhD, Abbott
ClinicalTrials.gov Identifier: NCT00645073     History of Changes
Other Study ID Numbers: M03-628
Study First Received: March 22, 2008
Last Updated: March 22, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Acute Bacterial Sinusitis

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cefdinir
Levofloxacin
Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2014