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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01212601
First received: September 16, 2010
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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
S. Aureus Bloodstream Infection

Study Type: Observational
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • AEs of CUBICIN therapy [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • clinical response of CUBICIN therapy at each available time point [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CPK level monitoring and results [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • treatment duration [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Time to clinical response [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 203
Study Start Date: January 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

Detailed Description:

MC MD

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Chinese patients received CUBICIN treatment

Criteria

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.
  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: NCT01212601

Locations
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
AstraZeneca
Investigators
Principal Investigator: Aixia Wang, Prof. Peiking Union Medical College Hospital
Study Director: Karen Atkin AstraZeneca
Study Chair: Mentha Wang AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01212601     History of Changes
Other Study ID Numbers: NIS-ICN-DUM-2010/1
Study First Received: September 16, 2010
Last Updated: November 23, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
safety
efficacy
Chinese patients
practice

ClinicalTrials.gov processed this record on September 16, 2014