A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia

NCT00236821 | Completed Phase 3

• 1 other identifier: CR005554
• Study Type: interventional
• Target: 530
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily.

Conditions

Pneumonia

Keywords

respiratory tract diseases; pneumonia; levofloxacin; community-acquired pneumonia; lung diseases; quinolones

Outcome Measures

Primary Outcomes (1)

• Clinical response rates based on signs and symptoms at posttherapy visit.

Secondary Outcomes (1)

• Microbiologic eradication rates at posttherapy visit; Clinical response rates (chest x-ray findings and signs/symptoms) and microbiologic eradication rates at poststudy; Incidence of adverse events

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 community-acquired pneumonia as follows: clinical signs and symptoms of a lower respiratory tract infection and chest-x-ray findings consistent with pneumonia within 24 hours before entry into the study
• At least one of the following: abnormal temperature (high or low) or abnormal white blood cell count
• Previous antibiotic treatment \<= 24 hours or, if the duration of treatment was \>= 72 hours and that therapy failed based on at least 2 of the following: fever within 12 hours of entry into the study, chest x-ray findings have worsened compared to the initial chest-x-ray, white blood cell count is significantly increased, respiratory rate higher than at the start of treatment and \>= 20 breaths per minute or need for supplemental oxygen if not previously needed
• Patients whose infection is acquired in the community or, if in a nursing home, who had been living there \< 14 days
• Fine Class (rating scale used to assess patients' overall condition which includes information such as age, gender, other diseases, physical examination and laboratory findings) score \<= 130 upon admission (patients with Fine Class scores \> 70 but \< = 130 must initially be hospitalized
• Patients with scores of \<= 70 may be treated as outpatients or hospitalized at the discretion of the investigator)

You may not qualify if:

• Pneumonia known or suspected to be due to a bacteria resistant to levofloxacin
• Previous allergic or serious reaction to or failed therapy with levofloxacin or similar drugs
• Life expectancy \< 72 hours
• Hospitalized within 2 weeks before entry in the study or within 1 month before entry in the study if treated with antibiotics
• Pneumonia acquired in a hospital
• Cystic fibrosis or other lung disorders
• Receiving chronic steroid treatment
• Received assistance from a machine to breathe within the previous month

Sponsors & Collaborators

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

Related Publications (1)

• Dunbar LM, Wunderink RG, Habib MP, Smith LG, Tennenberg AM, Khashab MM, Wiesinger BA, Xiang JX, Zadeikis N, Kahn JB. High-dose, short-course levofloxacin for community-acquired pneumonia: a new treatment paradigm. Clin Infect Dis. 2003 Sep 15;37(6):752-60. doi: 10.1086/377539. Epub 2003 Aug 28.

  PMID: 12955634 RESULT

Related Links

• A study to compare the safety and effectiveness of 2 doses of levofloxacin given for different time periods in patients with pneumonia

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Diseases; Community-Acquired Pneumonia; Lung Diseases

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Community-Acquired Infections

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 and 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: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: March 1, 2001
• Study Completion: June 1, 2002
• Last Updated: June 10, 2011

Record last verified: 2010-04