A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization
Nosocomial Pneumonia
About this trial
This is an interventional treatment trial for Nosocomial Pneumonia focused on measuring respiratory tract diseases, levofloxacin, pneumonia, quinolones, hospital-acquired pneumonia, lung diseases
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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