Impact of Antimicrobial Stewardship in Hospital: Eight Ye... | NCT02884687

Studies
Impact of Antimicrobial Stewardship in Hospital: Eight Years Review (BONANTIBIO)

NCT02884687

Sponsor

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Last Update Posted

Sep 1, 2016Estimated

Enrollment

18Actual

Phase

Not provided

Conditions

Good Use of Antibiotics

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 26, 2016

First Submission Date that Met QC Criteria

Aug 26, 2016

First Posted Date

Aug 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2016

Last Update Posted Date

Sep 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Detailed Description

The study focuses on the use of antibiotics in Regional Hospital Center Metz-Thionville (CHRMT) between 2007 and 2014. CHRMT is a 2000-bed hospital in which 160 000 short hospitalizations are performed. To analyze the strategies and decisions related to the appropriate use of antibiotics for this center, some Semi-Directive Interviews (SDI) are realized on the study period with all concerned actors of the Good Use of antibiotics. An interviewing plan and tree interview guidelines were created. All SDI are processed by the same person.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of the antibiotics use in the hospital compared with the efficacy indicators		2007 to 2014

Secondary Outcomes

Measure	Description	Time Frame
Antibiotics consumption		2007 to 2014
Bacterial resistance		2007 to 2014
Composite index of the appropriate use of the antibiotics

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

indication of antibiotics

Exclusion Criteria:

Non Applicable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All antibiotics delivery

Sampling Method

Non-Probability Sample