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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01667991
Other study ID # MDR in China 123
Secondary ID
Status Completed
Phase N/A
First received August 12, 2012
Last updated August 17, 2012
Start date April 2010
Est. completion date September 2011

Study information

Verified date August 2012
Source Southeast University, China
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Description:

All data concerning patient characteristics at ICU admission and during ICU stay were prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates from intubated patients and specimens from the infection location) was performed at ICU admission and discharge. Risk factors for infection or colonization with MDR bacteria were recorded, and the accuracy of the ATS criteria in predicting infection or colonization with these bacteria at ICU admission was documented. All of the infected patients were treated by the attending physician, and the choice and adjustment of antibiotic were in accordance with the recommendations of the ATS guidelines.


Recruitment information / eligibility

Status Completed
Enrollment 610
Est. completion date September 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Southeast University, China
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