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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.
 
ClinicalTrials.gov Identifier: NCT00645073
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date  ICMJE March 22, 2008
First Posted Date  ICMJE March 27, 2008
Last Update Posted Date March 27, 2008
Study Start Date  ICMJE November 2003
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2008)
Clinical cure rate [ Time Frame: 26 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2008)
  • Radiographic response [ Time Frame: 26 days ]
  • Changes from baseline in clinical signs and symptoms [ Time Frame: 26 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
Official Title  ICMJE A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Bacterial Sinusitis
Intervention  ICMJE
  • Drug: cefdinir (Omnicef)
    Two 300 mg cefdinir capsules on Study Days 1-10.
    Other Names:
    • ABT-198
    • Omnicef
    • cefdinir
  • Drug: levofloxacin
    Two 250 mg levofloxacin capsules on Study Days 1-10
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: cefdinir (Omnicef)
  • Active Comparator: B
    Intervention: Drug: levofloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2008)
271
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date March 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645073
Other Study ID Numbers  ICMJE M03-628
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angela M Nilius, PhD, Abbott
Study Sponsor  ICMJE Abbott
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP