An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01280461|
Recruitment Status : Unknown
Verified January 2011 by Taipei Medical University WanFang Hospital.
Recruitment status was: Enrolling by invitation
First Posted : January 20, 2011
Last Update Posted : January 20, 2011
|Condition or disease|
Patients fulfill inclusion/exclusion criteria will be randomly assigned (in a 1:1 ratio)to receive intravenous cefoperazone/sulbactam or intravenous cefepime for 7~21days. Vitamin K1 10mg will be administered to cefoperazone/sulbactam group every 24 hours.
The assessment of clinical sign and symptoms of pneumonia and microbiological tests will be performed at early post-therapy visit and test-of-cure visit.
|Study Type :||Observational|
|Estimated Enrollment :||142 participants|
|Official Title:||An Open-label, Randomized, and Comparative Study to Evaluate the Efficacy and Safety of Cefoperazone/Sulbactam in Comparison to Cefepime for the Treatment of Hospital-acquired Pneumonia and Healthcare-associated Pneumonia|
|Study Start Date :||July 2010|
|Estimated Study Completion Date :||December 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280461
|Taipei Medical University - WanFang Hospital|
|Principal Investigator:||Wen-Sen Lee||Taipei Medical University WanFang Hospital|