China Registration Study in Patients With Skin Infections

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Infectious

Skin Diseases

Treatments

Drug: Daptomycin

Drug: Vancomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00772447

D1790C00003

Details and patient eligibility

About

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.

Enrollment

265 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)