Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice
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
1 other identifier
observational
203
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 27, 2012
November 1, 2012
1.8 years
September 16, 2010
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AEs of CUBICIN therapy
2 weeks
clinical response of CUBICIN therapy at each available time point
2 weeks
Secondary Outcomes (3)
CPK level monitoring and results
2 weeks
treatment duration
2 weeks
Time to clinical response
2 weeks
Study Arms (1)
1
Eligibility Criteria
Chinese patients received CUBICIN treatment
You may qualify if:
- Patient has received CUBICIN treatment, decided by treating physician
- A patient who is considered as ethnic Chinese
- Provision of subject informed consent
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (18)
Research Site
Beijing, Beijing Municipality, China
Research Site
Fuzhou, Fujian, China
Research Site
Xiamen, Fujian, China
Research Site
Zhangzhou, Fujian, China
Research Site
Guangzhou, Guangdong, China
Research Site
Xingtai, Hebei, China
Research Site
Haerbing, Heilongjiang, China
Research Site
Zhenzhou, Henan, China
Research Site
Wuhan, Hubei, China
Research Site
Changzhou, Jiangsu, China
Research Site
Nanjing, Jiangsu, China
Research Site
Nantong, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
Research Site
Dalian, Liaoning, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Chengdu, Sichuan, China
Research Site
Tianjin, Tianjin Municipality, China
Research Site
Kunming, Yunnan, China
Study Officials
- PRINCIPAL INVESTIGATOR
Aixia Wang, Prof.
Peiking Union Medical College Hospital
- STUDY DIRECTOR
Karen Atkin
AstraZeneca
- STUDY CHAIR
Mentha Wang
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2010
First Posted
September 30, 2010
Study Start
January 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 27, 2012
Record last verified: 2012-11