Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01212601
Recruitment Status : Completed
First Posted : September 30, 2010
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):

Brief Summary:
This is a Multicenter, observational, non-interventional registry designed to collect clinical data in Chinese patients who have received CUBICIN treatment under condition of actual usage in clinical practice.

Condition or disease
S. Aureus Bloodstream Infection

Detailed Description:

Study Type : Observational
Actual Enrollment : 203 participants
Observational Model: Cohort
Official Title: A Multicenter, Observational, Non-interventional Registry Designed to Collect Clinical Data in Chinese Patients Who Have Received CUBICIN® Treatment Under Condition of Actual Usage in Clinical Practice
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin


Primary Outcome Measures :
  1. AEs of CUBICIN therapy [ Time Frame: 2 weeks ]
  2. clinical response of CUBICIN therapy at each available time point [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. CPK level monitoring and results [ Time Frame: 2 weeks ]
  2. treatment duration [ Time Frame: 2 weeks ]
  3. Time to clinical response [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese patients received CUBICIN treatment

Inclusion Criteria:

  • Patient has received CUBICIN treatment, decided by treating physician
  • A patient who is considered as ethnic Chinese
  • Provision of subject informed consent

Exclusion Criteria:

  • A patient record will not be eligible for the registry database if the patient received CUBICIN as part of a controlled clinical study for the current infection episode.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01212601

China, Beijing
Research Site
Beijing, Beijing, China
China, Fujian
Research Site
Fuzhou, Fujian, China
Research Site
Xiamen, Fujian, China
Research Site
Zhangzhou, Fujian, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hebei
Research Site
Xingtai, Hebei, China
China, Heilongjiang
Research Site
Haerbing, Heilongjiang, China
China, Henan
Research Site
Zhenzhou, Henan, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Changzhou, Jiangsu, China
Research Site
Nanjing, Jiangsu, China
Research Site
Nantong, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
China, Liaoning
Research Site
Dalian, Liaoning, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Tianjin
Research Site
Tianjin, Tianjin, China
China, Yunnan
Research Site
Kunming, Yunnan, China
Sponsors and Collaborators
Principal Investigator: Aixia Wang, Prof. Peiking Union Medical College Hospital
Study Director: Karen Atkin AstraZeneca
Study Chair: Mentha Wang AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT01212601     History of Changes
Other Study ID Numbers: NIS-ICN-DUM-2010/1
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: November 2012

Keywords provided by AstraZeneca:
Chinese patients

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents