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

NCT00236834 | Completed Phase 3

• 1 other identifier: CR005557
• Study Type: interventional
• Target: 438
• Locations: 0 countries
• Sites: N/A

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

Conditions

Nosocomial Pneumonia

Keywords

respiratory tract diseases; levofloxacin; pneumonia; quinolones, hospital-acquired pneumonia; lung diseases

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

levofloxacin; imipenem/cilastitin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PriCara, Unit of Ortho-McNeil, Inc.: collaborator

Related Publications (1)

• West M, Boulanger BR, Fogarty C, Tennenberg A, Wiesinger B, Oross M, Wu SC, Fowler C, Morgan N, Kahn JB. Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, randomized, open-label study. Clin Ther. 2003 Feb;25(2):485-506. doi: 10.1016/s0149-2918(03)80091-7.

  PMID: 12749509 RESULT

Related Links

• A study of the safety and effectiveness of levofloxacin compared with imipenem/cilastatin in patients with pneumonia acquired during hospitalization

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Respiratory Tract Diseases; Pneumonia; Lung Diseases

Interventions

Levofloxacin; Imipenem

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Respiratory Tract Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: December 1, 1997
• Study Completion: June 1, 2001
• Last Updated: June 10, 2011

Record last verified: 2010-04