China Registration Study in Patients with Skin Infections
Study identifier:D1790C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Skin Diseases
Phase
Phase 3
Healthy volunteers
No
Study drug
Daptomycin, Vancomycin
Sex
All
Actual Enrollment
265
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Sept 2008
Primary Completion Date: 01 Sept 2010
Study Completion Date: 01 Sept 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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 |
Contacts
Investigators
Principal Investigator
Karen Atkin
AstraZeneca
