China Registration Study in Patients With Skin Infections
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00772447
First received: October 9, 2008
Last updated: March 1, 2011
Last verified: March 2011
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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
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 June 17, 2013