- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128399
Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients
April 29, 2014 updated by: Jianfeng Xie
Antimicrobial exposure is known to reduce the selection for various drug-resistant organisms.
Numerous studies have demonstrated the association between antimicrobial use and MDR bacteria detection.
However, to the investigators knowledge, there is few data to support the concept that reducing antibiotic use actually leads to improvements in antibiotic susceptibilities.
Moreover, antimicrobial stewardship was demonstrated to reduce MDRO and was strongly recommended in clinics.
As the investigators know, antimicrobial overuse, which occurs commonly in China, induces a severe antibacterial resistance.
China's Ministry of Health (MOH) has established a policy about the antimicrobial stewardship.
To date, the investigators do not have published documentation the effects of this policy on multidrug-resistant organism (MDRO) in critically ill patients.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
978
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients who admitted into intensive care unit
Description
Inclusion Criteria:
- Patients hospitalized in the ICU
Exclusion Criteria:
- Patients who were readmitted to the ICU during a single hospital stay
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
patients before and after intervetion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of participates infection or colonization with MDRO in critically ill patients at ICU admission and discharge as a measure of effect of antimicrobial stewardship
Time Frame: up to 90 days
|
MDRO isolation from inclusion to the date of discharge of hospital, access up to 90 days
|
up to 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
April 22, 2014
First Submitted That Met QC Criteria
April 29, 2014
First Posted (Estimate)
May 1, 2014
Study Record Updates
Last Update Posted (Estimate)
May 1, 2014
Last Update Submitted That Met QC Criteria
April 29, 2014
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MDRO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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