Study identifier:D1790C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Skin Diseases
Phase 3
No
Daptomycin, Vancomycin
All
265
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
DALIAN, China
Location
Hangzhou, China
Location
QINGDAO, China
Location
Beijing, Beijing, China
Location
Guangzhou, Guangdong, China
Location
Wuhan, Hubei, China
Location
Changsha, Hunan, China
Location
Nanjing, Jiangsu, China
Arms | Assigned Interventions |
---|---|
Experimental: AZ drug Daptomycin | Drug: Daptomycin 4mg/kg IV ; Q 24 hr (once every 24 hours) Other Name: Cubicin® |
Active Comparator: Comparator Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin | 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 |
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