A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses

NCT00249210 | Completed Phase 3

• 1 other identifier: CR005485
• Study Type: interventional
• Target: 614
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.

Conditions

Sinusitis; Maxillary Sinusitis

Keywords

Sinusitis; respiratory tract diseases; nose diseases; respiratory tract infections; paranasal sinus diseases; antibacterial agents; quinolones; levofloxacin

Outcome Measures

Primary Outcomes (1)

• Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug

Secondary Outcomes (1)

• Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment

Interventions

levofloxacin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of rapid onset of severe inflammation/infection of the sinuses, as indicated by: fever, headache, discharge from the nose containing pus, facial pain, or tenderness in the area of the cheek bone
• x-ray at the start of the trial consistent with the diagnosis of severe inflammation/infection of the sinuses
• able to take oral medications

You may not qualify if:

• Patients with symptoms of sinusitis that has persisted longer than 4 weeks or who have had more than 2 previous episodes of rapid onset of severe inflammation/infection of the sinuses within 12 months prior to the trial
• previous allergic or serious adverse reaction to similar antibiotics
• specific blood and urine test results indicating kidney problems
• requirement of an antibiotic medication taken internally in addition to the study drug or have taken antibiotic medication within 48 hours prior to the start of the study and have experienced improvement
• seizure disorders or any condition requiring tranquilizers.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Links

• A study of the safety and effectiveness of levofloxacin compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses

MeSH Terms

Conditions

Sinusitis; Maxillary Sinusitis; Respiratory Tract Diseases; Nose Diseases; Respiratory Tract Infections; Paranasal Sinus Diseases

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 4, 2005
• First Posted: November 7, 2005
• Study Start: August 1, 1993
• Study Completion: July 1, 1994
• Last Updated: June 10, 2011

Record last verified: 2011-02