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

November 23, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

MC MD

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Fujian
      • Fuzhou, Fujian, China
        • Research Site
      • Xiamen, Fujian, China
        • Research Site
      • Zhangzhou, Fujian, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Hebei
      • Xingtai, Hebei, China
        • Research Site
    • Heilongjiang
      • Haerbing, Heilongjiang, China
        • Research Site
    • Henan
      • Zhenzhou, Henan, China
        • Research Site
    • Hubei
      • Wuhan, Hubei, China
        • Research Site
    • Jiangsu
      • Changzhou, Jiangsu, China
        • Research Site
      • Nanjing, Jiangsu, China
        • Research Site
      • Nantong, Jiangsu, China
        • Research Site
      • Suzhou, Jiangsu, China
        • Research Site
    • Liaoning
      • Dalian, Liaoning, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, China
        • Research Site
    • Yunnan
      • Kunming, Yunnan, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese patients received CUBICIN treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AEs of CUBICIN therapy
Time Frame: 2 weeks
2 weeks
clinical response of CUBICIN therapy at each available time point
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CPK level monitoring and results
Time Frame: 2 weeks
2 weeks
treatment duration
Time Frame: 2 weeks
2 weeks
Time to clinical response
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 16, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 27, 2012

Last Update Submitted That Met QC Criteria

November 23, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-ICN-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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