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levofloxacin; imipenem/cilastitin

Phase 3

Nosocomial Pneumonia | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Jun 10, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment438

FDA Designations

No designations recorded

Clinical trial landscape

levofloxacin; imipenem/cilastitin · 1 trial · 1 indication

Phase 3 1
NCT00236834A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During HospitalizationNosocomial Pneumonia
COMPLETED438 Analytics
PHASE3COMPLETED
A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization
Nosocomial Pneumonia
NCT00236834438
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
levofloxacin; imipenem/cilastitinDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 infec...

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