Status:
COMPLETED
A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Levofloxacin is an antibiotic that is approved by the FDA for the treatment of sinusitis, chronic bronchitis, skin infections, urinary tract infections, and community-acquired pneumonia. This multicen...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
530 Patients enrolled
Trial Details
Trial ID
NCT00236821
Start Date
March 1 2001
End Date
June 1 2002
Last Update
June 10 2011
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