A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

An Open-label, Multi-center, Non-comparative Sinus Puncture Study of 750 mg, Short-course Levofloxacin in the Treatment of Acute Maxillary Sinusitis

The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.

Levofloxacin 750 milligram tablet orally once a day for 5 days

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days
  • Visible nasal purulence evident on physical examination
  • CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level
  • Agree to a maxillary sinus puncture and catheter placement
  • If female, using birth control

Exclusion Criteria:

  • Chronic sinusitis
  • Need for hospitalization or intravenous antibiotics
  • History of head, neck, or nasal cancer or surgery
  • Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class
  • Presence or history of serious complications of sinusitis
  • Previous antimicrobial therapy within 7 days of Study Entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.

Secondary Outcome Measures

Outcome Measure
Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion

December 7, 2022

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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