A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236834
First received: October 7, 2005
Last updated: June 8, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to compare the safety and effectiveness of levofloxacin with imipenem/cilastatin in the treatment of hospital-acquired pneumonia


Condition Intervention Phase
Nosocomial Pneumonia
Drug: levofloxacin; imipenem/cilastitin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Microbiological response at posttherapy will be based on eradication or persistence of the pathogen(s) isolated at admission

Secondary Outcome Measures:
  • Clinical response at posttherapy will be based on the comparison of posttherapy signs/symptoms and radiological findings reported at posttherapy compared to those reported at admission. Clinical and microbiologic response at poststudy.

Enrollment: 438
Study Start Date: December 1997
Study Completion Date: June 2001
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236834

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00236834     History of Changes
Other Study ID Numbers: CR005557
Study First Received: October 7, 2005
Last Updated: June 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
respiratory tract diseases
levofloxacin
pneumonia
quinolones, hospital-acquired pneumonia
lung diseases

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cilastatin
Ofloxacin
Imipenem
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on April 17, 2014