China Registration Study in Patients With Skin Infections

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00772447
First received: October 9, 2008
Last updated: March 1, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Skin Diseases
Communicable Diseases
Drug: Daptomycin
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • AEs, changes in laboratory measurements (haematology, clinical chemistry, urinalysis and CPK levels) and changes in ECG. [ Time Frame: One-therapy evaluation on Day 3 or 4; End of therapy evaluation on 0-3 days after completion of study drug, Test of cure on 7-14 days after completion of study drug, Post-therapy evaluation on 21-28 days after completion of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate efficacy of Daptomycin (Cubicin®) in Chinese subjects with Gram positive cSSSI compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) [ Time Frame: End of therapy evaluation on 0-3 days after completion of study drug, Test of cure on 7-14 days after completion of study drug, Post-therapy evaluation on 21-28 days after completion of study drug ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: September 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Daptomycin
Drug: Daptomycin
4mg/kg iv q24hr.
Other Name: Cubicin®
Active Comparator: 2
Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin
Drug: Vancomycin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772447

Locations
China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdo
Research Site
Guangzhou, Guangdo, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Hunan
Research Site
Changsha, Hunan, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
China, Liaoning
Research Site
Shenyang, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China
Research Site
Chongqing, China
Research Site
Dalian, China
Research Site
Hangzhou, China
Research Site
Qingdao, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Atkin AstraZeneca
Principal Investigator: Zhang Yingyuan, Prof. Antibiotics Institute, Huashan Hospital Affilicated to Fudan University
  More Information

No publications provided

Responsible Party: Karen Atkin, VP China R&D, AstraZeneca Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00772447     History of Changes
Other Study ID Numbers: D1790C00003
Study First Received: October 9, 2008
Last Updated: March 1, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Skin Infections
Complicated Bacterial Skin and Skin Structure Infection due to Gram-positive Pathogens

Additional relevant MeSH terms:
Communicable Diseases
Infection
Skin Diseases
Skin Diseases, Infectious
Cloxacillin
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014