A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. - Full Text View

Sponsors and Collaborators:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00236522

Purpose

The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once daily.

Condition	Intervention	Phase
Sinusitis	Drug: levofloxacin	Phase III

MedlinePlus related topics: Sinusitis

Drug Information available for: Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Levofloxacin 750 mg Once Daily for 5 Days Versus Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Clinical success (resolution of patient signs and symptoms) at the post-therapy visit.

Secondary Outcome Measures:

Microbiologic response at the post-therapy visit and safety evaluations.

Estimated Enrollment:	530
Study Start Date:	October 2002
Estimated Study Completion Date:	April 2004

Detailed Description:

When treating sinus infections (sinusitis) caused by bacteria, the traditional duration of therapy is between 10 and 14 days. In this randomized, double-blind study, 5 days of 750 milligrams of levofloxacin given once daily will be compared to 10 days of 500 milligrams of levofloxacin in the treatment of non-hospitalized adult patients who have acute bacterial sinusitis. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. Patients will have a sinus specimen collected at the first visit. Safety evaluations will be conducted. The objective of the study is to demonstrate that, in the treatment of acute bacterial sinus infections, a 5-day course of 750 milligrams of levofloxacin given once daily is at least as effective as a 10-day course of 500 milligrams of levofloxacin given once daily and is well tolerated.

Patients will take by mouth 750 milligrams levofloxacin capsules once daily for 5 days followed by placebo capsules once daily for 5 days, or 500 milligrams levofloxacin capsules once daily for 10 days.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of acute bacterial sinusitis, defined by clinical signs and symptoms lasting for less than 28 days and the presence of visible nasal infection, and confirmed by computed tomography (CT) or standard sinus x-rays
Two or fewer episodes of bacterial sinusitis within the preceding 12 months
Willing to undergo maxillary sinus puncture or endoscopy

Exclusion Criteria:

Chronic sinusitis
Use of systemic antibiotics within the past 72 hours
Presence or history of serious complications of sinusitis
Surgery for treating sinusitis
Required daily use of more than 20 milligrams of prednisone (oral steroid)
Cystic fibrosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236522

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Levofloxacin 750 mg Once Daily for 5 Days Versus Levofloxacin 500 mg Once Daily for 10 days in the Treatment of Acute Bacterial Sinusitis in Adults This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR002809
Study First Received:	October 7, 2005
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00236522
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

sinusitis
sinus infection
bacterial sinus infection
acute bacterial sinusitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ofloxacin
Sinusitis

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Paranasal Sinus Diseases
Therapeutic Uses
Anti-Infective Agents, Urinary

Enzyme Inhibitors
Renal Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009