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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bacterial Sinusitis

Intervention: cefdinir (Omnicef) (Drug); levofloxacin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Abbott

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.

Clinical Details

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

Primary outcome: Clinical cure rate

Secondary outcome:

Radiographic response

Changes from baseline in clinical signs and symptoms

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Gorzow Wielkopolski 66-400, Poland

Krakow 30-510, Poland

Krakow 31-513, Poland

Lodz 90-430, Poland

Lodz 92-215, Poland

Przybyslawice 322-088, Poland

Skierniewice 96-100, Poland

Szczecin 70-344, Poland

Szczecin 70-506, Poland

Szczecin 71-667, Poland

Birmingham, Alabama 35215, United States

Birmingham, Alabama 35211, United States

Columbiana, Alabama 35051, United States

Eclectic, Alabama 36024, United States

Tuscaloosa, Alabama 35406, United States

Mesa, Arizona 85201, United States

Fresno, California 93710, United States

Fresno, California 93703, United States

Murray, Kentucky 42071, United States

Portage, Michigan 49024, United States

Eugene, Oregon 97404, United States

Lake Oswego, Oregon 97035, United States

Orangeburg, South Carolina 29118, United States

Kingsport, Tennessee 37660, United States

Milan, Tennessee 38358, United States

Corsicana, Texas 75110, United States

San Antonio, Texas 78205, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

West Jordan, Utah 84084, United States

West Jordan, Utah 84088, United States

Winchester, Virginia 22601, United States

Spokane, Washington 99204, United States

Additional Information

Starting date: November 2003
Last updated: March 22, 2008

Page last updated: August 23, 2015

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