NCT03752476

Brief Summary

This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug resistant bacteria colonization in intensive care It's retrospective case controle study. Cases are colonized patient by multidrug resistant bacteria hospitalized in intensive care during the fist hospitalization in intensive care. Temoin are patients with the same characteristics than case but no colonized by multidrug resistant bacteria.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

November 21, 2018

Last Update Submit

November 21, 2018

Conditions

Resistant InfectionAntibiotic Resistant InfectionBeta Lactam Resistant Bacterial InfectionBacterial Resistance

Keywords

antibiotic resistantmultidrug resistantBeta lactam

Outcome Measures

Primary Outcomes (1)

  • number of Beta lactam class prescription

    3 months

Study Arms (2)

case

Patients are colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.

Procedure: number of Beta lactam class prescription for the same infection

control

Patients aren't colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.

Procedure: number of Beta lactam class prescription for the same infection

Interventions

number of Beta lactam class prescription for the same infectionPROCEDURE

Each number of Beta lactam prescription without interruption are compared

casecontrol

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017

You may qualify if:

  • all patient hospitalized more than 48 hours in intensive care unit in Besançon between january 2016 and december 2017

You may not qualify if:

  • patient under guardianship
  • patient allergic to Beta lactam
  • colonization with mutidrug resistant the first week of hospitalization in intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

ESTELLE DOSSOT

CONTACT

+33645578372estelle.dossot@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

January 1, 2019

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

November 26, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share