S. Aureus Bloodstream InfectionNCT01212601
Collect Clinical Data in Chinese Patients Received CUBICIN Treatment for Actual Usage in Clinical Practice
An observational study of S. Aureus Bloodstream Infection, run by AstraZeneca at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- S. Aureus Bloodstream Infection
- How many people
- 203 participants
- Where
- 18 sitesChina
- Study dates
- Jan 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese patients received CUBICIN treatment
Who may be able to join
- Patient has received CUBICIN treatment, decided by treating physician
- A patient who is considered as ethnic Chinese
- Provision of subject informed consent
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changzhou, Jiangsu
Research Site
Chengdu, Sichuan
Research Site
Dalian, Liaoning
Research Site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Haerbing, Heilongjiang
Research Site
Kunming, Yunnan
Research Site
Nanjing, Jiangsu
Research Site
Nantong, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Suzhou, Jiangsu
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
Research Site
Xiamen, Fujian
Research Site
Xingtai, Hebei
Research Site
Zhangzhou, Fujian
Research Site
Zhenzhou, Henan
About this study
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
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.
Read the detailed description
MC MD
- Conditions
- S. Aureus Bloodstream Infection
- Keywords
- safety, efficacy, Chinese patients, practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs of CUBICIN therapy
Measured: 2 weeks
clinical response of CUBICIN therapy at each available time point
Measured: 2 weeks
Secondary outcomes (3)
CPK level monitoring and results
Measured: 2 weeks
treatment duration
Measured: 2 weeks
Time to clinical response
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for S. Aureus Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aixia Wang, Prof., Principal investigator, Peiking Union Medical College HospitalKaren Atkin, Study director, AstraZenecaMentha Wang, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212601
- Sponsor's protocol ID
- NIS-ICN-DUM-2010/1
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01212601
- Acronym / sponsor ID
- NIS-ICN-DUM-2010/1
- Conditions
- S. Aureus Bloodstream Infection
- Keywords
- safety, efficacy, Chinese patients, practice
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese patients received CUBICIN treatment
Key inclusion criteria (3 listed)
- Patient has received CUBICIN treatment, decided by treating physician
- A patient who is considered as ethnic Chinese
- Provision of subject informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AEs of CUBICIN therapy
Time frame: 2 weeks
clinical response of CUBICIN therapy at each available time point
Time frame: 2 weeks
3 secondary outcomes
CPK level monitoring and results
Time frame: 2 weeks
treatment duration
Time frame: 2 weeks
Time to clinical response
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aixia Wang, Prof. principal investigator
Peiking Union Medical College Hospital
Karen Atkin study director
AstraZeneca
Mentha Wang study chair
AstraZeneca
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of S. Aureus Bloodstream Infection, run by AstraZeneca at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs of CUBICIN therapy (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.