Clinical trial NCT00645073: Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Bacterial Sinusitis
Keywords: Acute Bacterial Sinusitis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Clinical cure rate
timeFrame: 26 days
Secondary outcomes:
measure: Radiographic response
timeFrame: 26 days
measure: Changes from baseline in clinical signs and symptoms
timeFrame: 26 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Eclectic
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: Fresno
country: United States
state: California
city: Murray
country: United States
state: Kentucky
city: Portage
country: United States
state: Michigan
city: Eugene
country: United States
state: Oregon
city: Lake Oswego
country: United States
state: Oregon
city: Orangeburg
country: United States
state: South Carolina
city: Kingsport
country: United States
state: Tennessee
city: Milan
country: United States
state: Tennessee
city: Corsicana
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Winchester
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Gorzow Wielkopolski
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Przybyslawice
country: Poland
city: Skierniewice
country: Poland
city: Szczecin
country: Poland
city: Szczecin
country: Poland
city: Szczecin
country: Poland
Study officials:
References: