Status:
COMPLETED
China Registration Study in Patients With Skin Infections
Lead Sponsor:
AstraZeneca
Conditions:
Skin Diseases
Infectious
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Provision of inform consent
- A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
- Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing
Exclusion
- Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
- Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
- Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
- Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00772447
Start Date
September 1 2008
End Date
September 1 2010
Last Update
March 9 2015
Active Locations (13)
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1
Research Site
Beijing, Beijing Municipality, China
2
Research Site
Guangzhou, Guangdong, China
3
Research Site
Wuhan, Hubei, China
4
Research Site
Changsha, Hunan, China