NCT01667991

Brief Summary

Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are different between countries, will affect the accuracy of etiological diagnoses according to the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria in China.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
Last Updated

August 20, 2012

Status Verified

August 1, 2012

First QC Date

August 12, 2012

Last Update Submit

August 17, 2012

Conditions

Keywords

Colonizationinfectionmultidrug-resistant bacteriaguideline

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients admitted to icu

You may qualify if:

  • All patients hospitalized in the ICU were eligible for this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Xie J, Ma X, Huang Y, Mo M, Guo F, Yang Y, Qiu H. Value of American Thoracic Society guidelines in predicting infection or colonization with multidrug-resistant organisms in critically ill patients. PLoS One. 2014 Mar 19;9(3):e89687. doi: 10.1371/journal.pone.0089687. eCollection 2014.

MeSH Terms

Conditions

Infections

Study Officials

  • Jianfeng Xie, MD

    Zhongda Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Critical Care Medicine, Zhong-Da Hospital, School of Medicine Southeast University

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 17, 2012

Study Start

April 1, 2010

Study Completion

September 1, 2011

Last Updated

August 20, 2012

Record last verified: 2012-08