Nosocomial Pneumonia Clinical Trial
Official title:
A Multicenter, Randomized, Open Label Study to Compare the Safety and Efficacy of Levofloxacin With That of Imipenem/Cilastatin in the Treatment of Nosocomial Pneumonia
The purpose of this study is to compare the safety and effectiveness of levofloxacin with imipenem/cilastatin in the treatment of hospital-acquired pneumonia
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 patients who acquire pneumonia while in the hospital die from
complications of pneumonia). Levofloxacin has been shown in clinical trials to be effective
against a number of different bacteria, including those found to be common and uncommon
causes of pneumonia. This multicenter, open-label study evaluates the safety and
effectiveness of levofloxacin as compared with imipenem/cilastatin, another type of
antibiotic treatment, in patients with pneumonia acquired in the hospital. Patients receive
treatment for a total of 7-15 days, initially with levofloxacin or imipenem/cilastatin,
administered slowly through a vein. If patients respond positively to either drug, treatment
may be changed to levofloxacin or ciprofloxacin (if initially treated with
imipenem/cilastatin), to be taken by mouth. Certain additional drugs may be added if needed
to treat pneumonia caused by certain bacteria. Patients showing signs of improvement
continue in the study, with assessments 5-7 days (posttherapy visit) and 28-32 days after
completion of the study drug (poststudy visit). Effectiveness is assessed by measuring the
ability of the study drug to eliminate bacteria causing pneumonia and to reduce the signs
and symptoms of pneumonia. Chest x-rays and laboratory tests for bacteria are performed
throughout the study and patients' severity of disease is rated according to the Acute
Physiology And Chronic Health Evaluation (APACHE) scale. Safety evaluations (incidence of
adverse events, physical examinations, laboratory tests) are performed throughout the study.
Blood samples are drawn from patients receiving levofloxacin to determine the concentration
of levofloxacin in the blood. The study hypothesis is that levofloxacin is at least as
effective as imipenem/cilastatin in treating hospital-acquired pneumonia and is generally
well-tolerated.
Levofloxacin 750 mg administered through a vein once daily or imipenem/cilastatin 500mg-1
gram every 6-8 hours. Upon improvement, patients may transition to levofloxacin 750mg by
mouth once daily or ciprofloxacin 750mg by mouth twice daily for 7-15 days.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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