Prognostic Factors and Therapeutic Management of ESBL Ent... | NCT05833282

Studies
Prognostic Factors and Therapeutic Management of ESBL Enterobacteriaceae in the ICU

NCT05833282

Sponsor

Tourcoing Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Drug Resistance, Multiple, Bacterial

Interventions

Not provided

Countries

France

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Apr 4, 2023

First Submission Date that Met QC Criteria

Apr 26, 2023

First Posted Date

Apr 27, 2023Actual

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

Apr 26, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Multicenter retrospective study conducted in the intensive care units of Tourcoing, Roubaix, and Lille hospitals. Patients hospitalized in the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU will be selected from microbiology laboratory data. Patient demographics and clinical data will be collected from the medical record. Microbiological results will be collected from the laboratory data.

Detailed Description

INCLUSION CRITERIA - Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

PRIMARY ENDPOINT

- The primary endpoint is 30-day mortality.

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint is all-cause 30-day mortality.	all-cause mortality.	30-day mortality

Secondary Outcomes

Measure	Description	Time Frame
Adequacy of initial antibiotic therapy to french recommendations	Antibiotic prescriptions will be considered adequate if all of the following criteria meet the recommendations: molecule, dose, according to the recommendations provided by the French Society of Infectious Diseases. The recommendations for prescribing antibiotics are similar to those proposed by international guidelines.	adequate within 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU with EBLSE bacteremia within 24 hours before or during their stay in the ICU.

Exclusion Criteria:

Patient who is a minor, protected adult, or who refuses to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the ICU with EBLSE bacteremia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MEYBECK Angès, MD	Contact	0320694238		recherche@ch-tourcoing.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier DRON	Recruiting	Tourcoing		59208	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided