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

Acute Bacterial Sinusitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645073
• Other study ID #: M03-628
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2008
• Last updated: March 22, 2008
• Start date: November 2003

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bacterial Sinusitis
• Sinusitis

Intervention

Drug:
• cefdinir (Omnicef)
Two 300 mg cefdinir capsules on Study Days 1-10.
• levofloxacin
Two 250 mg levofloxacin capsules on Study Days 1-10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure rate		26 days	No
Secondary	Radiographic response		26 days	No
Secondary	Changes from baseline in clinical signs and symptoms		26 days	No