NCT02128399

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
978

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

July 1, 2012

Enrollment Period

11 months

First QC Date

April 22, 2014

Last Update Submit

April 29, 2014

Conditions

Sepsis

Keywords

antimicrobial stewardship

Outcome Measures

Primary Outcomes (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

    MDRO isolation from inclusion to the date of discharge of hospital, access up to 90 days

    up to 90 days

Study Arms (1)

patients before and after intervetion

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who admitted into intensive care unit

You may qualify if:

  • Patients hospitalized in the ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ma X, Xie J, Yang Y, Guo F, Gao Z, Shao H, Huang Y, Yang C, Qiu H. Antimicrobial stewardship of Chinese ministry of health reduces multidrug-resistant organism isolates in critically ill patients: a pre-post study from a single center. BMC Infect Dis. 2016 Nov 25;16(1):704. doi: 10.1186/s12879-016-2051-8.

    PMID: 27887595DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor of department of critical care medicine

Study Record Dates

First Submitted

April 22, 2014

First Posted

May 1, 2014

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

December 1, 2013

Last Updated

May 1, 2014

Record last verified: 2012-07