Nosocomial InfectionNCT01943331
Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU
An observational study of Nosocomial Infection, run by Southeast University, China at 1 site in China.
Trial summary
The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nosocomial Infection
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Mar 2018
- 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: All patients admitted into ICU are eligible for this study. All the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of ATS guidelines.
Inclusion Criteria:all patients admitted into ICU
Trial locations and contacts
1 site in 1 country.
Jianfeng Xie contact
China1 site, 1 recruiting
- Recruiting
Department of Critical Care , Zhong-da Hospital
Nanjing, Jiangsu, 210009
Jianfeng Xie, seuicu@yahoo.com.cn
About this study
Official title: Colonization and Infection in Critically Ill Patients: a Multicenter, Prospective, Observational Study in Intensive Care Units (ICUs) in China
The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection.
Read the detailed description
The objectives are as followings:
- Obtain incidence of three major nosocomial infection in ICU, catheter related blood stream infection(CRBSI), catheter related urinary tract infection (CRUTI), and ventilator associated pneumonia (VAP).
- Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.
- Conditions
- Nosocomial Infection
- Medical subject headings
- Cross Infection
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 |
|---|---|---|
| patients admitted to ICU | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
the incidence rate of VAP, CRBSI,CAUTI of critical ill patients in Chinese ICU
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nosocomial InfectionStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
- Investigators
- Jianfeng Xie, Principal investigator, Department of Critical Care Medicine, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943331
- Sponsor's protocol ID
- nosocomial infection in ICU
- Status last verified
- Apr 2013
- First submitted
- 30 Mar 2013
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xie J, Yang Y, Huang Y, Kang Y, Xu Y, Ma X, Wang X, Liu J, Wu D, Tang Y, Qin B, Guan X, Li J, Yu K, Liu D, Yan J, Qiu H. The Current Epidemiological Landscape of Ventilator-associated Pneumonia in the Intensive Care Unit: A Multicenter Prospective Observational Study in China. Clin Infect Dis. 2018 Nov 13;67(suppl_2):S153-S161. doi: 10.1093/cid/ciy692.
PubMed 30423055
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonization and Infection in Critically Ill Patients: a Multicenter, Prospective, Observational Study in Intensive Care Units (ICUs) in China
- ClinicalTrials.gov ID
- NCT01943331
- Acronym / sponsor ID
- nosocomial infection in ICU
- Conditions
- Nosocomial Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2018 (estimated)
- First posted
- 16 Sep 2013 (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.
The current protocol desires to implement a large-multicenter observational study of hospital acquired infection in ICU in China. The study will generate data on generate data about the epidemiology current management of nosocomial infection.
Detailed description
The objectives are as followings:
- Obtain incidence of three major nosocomial infection in ICU, catheter related blood stream infection(CRBSI), catheter related urinary tract infection (CRUTI), and ventilator associated pneumonia (VAP).
- Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients admitted to ICU | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted into ICU are eligible for this study. All the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of ATS guidelines.
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
morbidity
Time frame: one year
the incidence rate of VAP, CRBSI,CAUTI of critical ill patients in Chinese ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Derived from this study: PubMed 30423055Xie J, Yang Y, Huang Y, Kang Y, Xu Y, Ma X, Wang X, Liu J, Wu D, Tang Y, Qin B, Guan X, Li J, Yu K, Liu D, Yan J, Qiu H. The Current Epidemiological Landscape of Ventilator-associated Pneumonia in the Intensive Care Unit: A Multicenter Prospective Observational Study in China. Clin Infect Dis. 2018 Nov 13;67(suppl_2):S153-S161. doi: 10.1093/cid/ciy692.
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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.
Jianfeng Xie contact
Jianfeng Xie principal investigator
Department of Critical Care Medicine, Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nosocomial Infection, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Xie (seuicu@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943331, which also lists 1 linked publication.
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 17 Feb 2016.