Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antimicrobial Stewardship Reduces MDRO Isolates in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128399
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Jianfeng Xie, Southeast University, China

Brief Summary:
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.

Condition or disease
Sepsis

Layout table for study information
Study Type : Observational
Actual Enrollment : 978 participants
Time Perspective: Prospective
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort
patients before and after intervetion



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who admitted into intensive care unit
Criteria

Inclusion Criteria:

  • Patients hospitalized in the ICU

Exclusion Criteria:

  • Patients who were readmitted to the ICU during a single hospital stay

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jianfeng Xie, doctor of department of critical care medicine, Southeast University, China
ClinicalTrials.gov Identifier: NCT02128399     History of Changes
Other Study ID Numbers: MDRO
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: July 2012

Keywords provided by Jianfeng Xie, Southeast University, China:
antimicrobial stewardship

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Infective Agents
Anti-Bacterial Agents