Epidemiological Investigation of CRBSI, VAP, CAUTI in Chi... | NCT01943331

Studies
Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU

NCT01943331

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Feb 17, 2016Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Nosocomial Infection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2018Estimated

Completion Date

Not provided

First Submitted Date

Mar 30, 2013

First Submission Date that Met QC Criteria

Sep 11, 2013

First Posted Date

Sep 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2016

Last Update Posted Date

Feb 17, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jianfeng Xie, Department of critical care medicine, Zhongda Hospital, Southeast University, ChinaPrincipal Investigator

Lead Sponsor

Southeast University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
patients admitted to ICU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
morbidity	the incidence rate of VAP, CRBSI,CAUTI of critical ill patients in Chinese ICU	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:all patients admitted into ICU

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Xie	Contact			seuicu@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Jianfeng Xie	Department of Critical Care Medicine, Zhongda Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Critical Care , Zhong-da Hospital	Recruiting	Nanjing	Jiangsu	210009	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30423055	Derived	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.

ID	Term
D007239	Infections
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes