A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia

NCT00257049 | Completed Phase 2

• 1 other identifier: CR005491
• Study Type: interventional
• Target: 604
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is evaluation of the safety and effectiveness of levofloxacin, an antibiotic, compared with ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia.

Conditions

Pneumonia

Keywords

Pneumonia; lung inflammation; bacterial pneumonia; lung diseases; respiratory tract infections; antibacterial agents; quinolones; levofloxacin

Outcome Measures

Primary Outcomes (1)

• Clinical response rate (reduction in signs and symptoms, improvement in x-ray findings) at post-therapy (5 - 7 days after the last dose of study drug).

Secondary Outcomes (1)

• Rate of elimination of disease-causing bacteria, by patient, and by type of bacteria; incidence of adverse events; changes in physical examination and laboratory tests after treatment with study drug

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 pneumonia based upon clinical signs and symptoms of a lower respiratory tract infection including at least 2 of the following: fever, cough, greenish-yellow mucus produced on coughing, chest pain, shortness of breath, or evidence of decreased lung function during the physical examination
• has chest x-ray findings consistent with acute pneumonia
• previously received antibiotics for pneumonia if the duration of therapy was \<= 24 hours, or if greater than 24 hours, but without improvement or stabilization with that therapy.

You may not qualify if:

• Previous allergic or serious adverse reaction to any antibiotic similar to those used in this study or to penicillin
• collection of pus in the cavity between the lung and the membrane that surrounds it
• has cystic fibrosis
• has a lung infection due to fungus, bacteria, or virus known prior to the start of the study to be resistant to any of the study drugs
• has severe kidney failure, decrease in white blood cell count, seizure disorder, or an unstable psychiatric condition.

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 ceftriaxone sodium or cefuroxime axetil in the treatment of adults with pneumonia

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Lung Diseases; Respiratory Tract Infections

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: January 1, 1984
• Study Completion: January 1, 1995
• Last Updated: June 10, 2011

Record last verified: 2010-11