NCT00772447

China Registration Study in Patients With Skin Infections

A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.

Conditions

• Skin Diseases
• Infectious

Interventions

Type	Name	Description
DRUG	Daptomycin	4mg/kg IV ; Q 24 hr (once every 24 hours)
DRUG	Vancomycin	Vancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: \- 1 g every 6 hours or 2 g every 8 hours

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2008-10-15
• Last updated: 2015-03-09
• Results posted: 2015-03-09

Locations

13 sites across 1 country: China