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levofloxacin; imipenem/cilastitin

Phase 3

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

levofloxacin; imipenem/cilastitin development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2005

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment438

FDA Designations

No designations recorded

levofloxacin; imipenem/cilastitin clinical trials

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 PneumoniaUnlock trial analytics

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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Frequently asked questions about levofloxacin; imipenem/cilastitin

What is levofloxacin used for in nosocomial pneumonia?

Levofloxacin was studied as a treatment for nosocomial pneumonia, which is pneumonia acquired during hospitalization. It was evaluated in a Phase 3 trial comparing it with imipenem/cilastatin in patients with this condition. Levofloxacin is a small molecule anti-infective developed by Johnson & Johnson.

Who makes levofloxacin?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of levofloxacin. The company sponsored the Phase 3 study of levofloxacin in nosocomial pneumonia. Johnson & Johnson is a large healthcare and pharmaceutical company.

What phase is levofloxacin in for nosocomial pneumonia?

Levofloxacin reached Phase 3 development for nosocomial pneumonia. The Phase 3 trial, NCT00236834, has been completed. Levofloxacin is an investigational treatment in this setting and remains in clinical development for the indication studied.

What clinical trial is levofloxacin in for nosocomial pneumonia?

Levofloxacin was evaluated in the Phase 3 trial NCT00236834, titled A Study of the Safety and Effectiveness of Levofloxacin Compared With Imipenem/Cilastatin in Patients With Pneumonia Acquired During Hospitalization. The completed trial enrolled 438 patients aged 18 years and older and compared levofloxacin with imipenem/cilastatin.

How many patients were enrolled in the levofloxacin nosocomial pneumonia trial?

The Phase 3 trial NCT00236834 enrolled 438 patients with nosocomial pneumonia. Participants were 18 years of age or older, and both sexes were eligible. The study was randomized and compared levofloxacin with imipenem/cilastatin. The trial has been completed.