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NCT01943331 Clinical Trial

Epidemiological Investigation of CRBSI, VAP, CAUTI in Chinese ICU

Nosocomial Infection Clinical Trial

Official title:
Colonization and Infection in Critically Ill Patients: a Multicenter, Prospective, Observational Study in Intensive Care Units (ICUs) in China

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01943331
Other study ID # nosocomial infection in ICU
Secondary ID
Status Recruiting
Phase N/A
First received March 30, 2013
Last updated February 14, 2016
Start date March 2013

Study information
Verified date April 2013
Source Southeast University, China
Contact Jianfeng Xie
Email seuicu@yahoo.com.cn
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical 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.

Description:

The objectives are as followings:

1. 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).

2. Determine the epidemic of etiology and condition of management of three major nosocomial infection in ICU in China.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:all patients admitted into ICU

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Department of Critical Care , Zhong-da Hospital Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary morbidity the incidence rate of VAP, CRBSI,CAUTI of critical ill patients in Chinese ICU one year No
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