Clinical trial NCT01212601: Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: S. Aureus Bloodstream Infection
Keywords: safety
efficacy
Chinese patients
practice
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients received CUBICIN treatment

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.

Detailed description: MC MD

Eligibility 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.

Primary outcomes:
measure: AEs of CUBICIN therapy
timeFrame: 2 weeks
measure: clinical response of CUBICIN therapy at each available time point
timeFrame: 2 weeks
Secondary outcomes:
measure: CPK level monitoring and results
timeFrame: 2 weeks
measure: treatment duration
timeFrame: 2 weeks
measure: Time to clinical response
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Fuzhou
country: China
facility: Research Site
state: Fujian
city: Xiamen
country: China
facility: Research Site
state: Fujian
city: Zhangzhou
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Xingtai
country: China
facility: Research Site
state: Hebei
city: Haerbing
country: China
facility: Research Site
state: Heilongjiang
city: Zhenzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changzhou
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Nantong
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Kunming
country: China
facility: Research Site
state: Yunnan
Study officials:
affiliation: Peiking Union Medical College Hospital
name: Aixia Wang, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Karen Atkin
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Mentha Wang
role: STUDY_CHAIR
References: