NCT01280461

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 142 (estimated)
• Sponsor: Taipei Medical University WanFang Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, multi-center, open-label, comparative and randomized study in evaluating the efficacy and safety of cefoperazone/sulbactam versus cefepime for the treatment of hospital-acquired pneumonia and healthcare-associated pneumonia. The investigator will determine the total duration of study therapy, as clinically indicated. The minimum duration of study therapy will be 7 days and the maximum allowable duration of study therapy will be 21 days.

Detailed description

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.

Conditions

• Pneumonia

Timeline

• Start date: 2010-07-01
• Completion: 2011-12-01
• First posted: 2011-01-20
• Last updated: 2011-01-20

Locations

1 site across 1 country: Taiwan