Status:
COMPLETED
A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Nosocomial Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and effectiveness of levofloxacin with imipenem/cilastatin in the treatment of hospital-acquired pneumonia
Detailed Description
Despite advances in prevention and treatment, hospital-acquired pneumonia remains a significant problem as the second most common infection acquired in the hospital and the most deadly (20%-50% of pat...
Eligibility Criteria
Inclusion
- Diagnosis of hospital-acquired pneumonia as follows: hospitalization \>= 48 but \<= 72 hours, identification of a bacteria commonly found in hospital-acquired infections, absence of pneumonia on initial chest x-ray, normal white blood cell count, and diagnosis other than infection upon admission to hospital OR hospitalized \>= 72 hours OR discharged from a hospital \<= 48 hours after a hospitalization of \>= 72 hours AND chest x-ray findings consistent with infection AND abnormal temperature (high or low) or abnormal white blood cell count
- Specimen from respiratory tract is available for laboratory analysis
- APACHE score \<= 35
- Have received at least 72 hours of treatment with antibiotics administered intravenously (through a vein) and have failed that treatment providing the previous drugs were not levofloxacin or imipenem/cilastatin and there is evidence of failure (specimen from respiratory tract documenting original bacteria causing pneumonia is still present or presence of a new bacteria causing pneumonia acquired in the hospital, continued abnormal temperature or worsening of x-ray findings and at least 1 of the following: increased white blood cell count or decrease in breathing ability/increase in oxygen requirements)
- Have received treatment with antibiotics administered intravenously (through a vein) for \< 24 hours within 72 hours prior to study entry
- Hospitalized for \>= 72 hours and develop acute signs and symptoms of pneumonia while on antibiotic(s) for another reason, providing that the previous antibiotic(s) were not levofloxacin or imipenem/cilastatin, no antibiotics have been given for the pneumonia and the previous antibiotic(s) can be discontinued
Exclusion
- Infection due to a bacteria that is know to be resistant to levofloxacin or imipenem or certain other drugs that may be used during the study
- Have received treatment with antibiotics administered intravenously for \> 24 hours within 72 hours prior to study entry
- Previous allergic or serious adverse reaction to any of the drugs used in this study or to a drug similar to those used in this study
- Cystic fibrosis or other lung disorder or an infection not treatable with antibiotics
- Significantly decreased kidney function
- Pre-infection terminal illness (such as cancer)
- Decreased white blood cell count
Key Trial Info
Start Date :
December 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT00236834
Start Date
December 1 1997
End Date
June 1 2001
Last Update
June 10 2011
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