China Registration Study in Patients With Skin Infections

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

265 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Skin Diseases Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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AZ drug

Daptomycin

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

4mg/kg IV ; Q 24 hr (once every 24 hours)

Comparator

Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Group Type ACTIVE_COMPARATOR

Vancomycin

Intervention Type DRUG

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

Interventions

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Daptomycin

4mg/kg IV ; Q 24 hr (once every 24 hours)

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Cubicin®

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No