Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) (ZEPHYR)
Tracking Information
Start Date ICMJE | October 2004 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: December 4, 2009) | To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults. [ Time Frame: up to 30 d after completion of treatment ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: September 8, 2005) | To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults |
Change History | Complete list of historical versions of study NCT00084266 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 4, 2009) | To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults. [ Time Frame: up to 30 days after end of treatment ] [ Designated as safety issue: Yes ] |
Original Secondary Outcome Measures ICMJE (submitted: September 8, 2005) | To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults |
Descriptive Information
Brief Title ICMJE | Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) |
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Official Title ICMJE | Linezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus |
Brief Summary | To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to MRSA in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin. |
Detailed Description | |
Study Phase | Phase IV |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Pneumonia, Staphylococcal |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1200 | ||||
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Estimated Completion Date | June 2010 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Belgium, Brazil, Chile, Colombia, France, Germany, Greece, Hong Kong, Korea, Republic of, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Russian Federation, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00084266 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A5951001 | ||||
Study Sponsor ICMJE | Pfizer | ||||
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Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/