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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02891902
Other study ID # RC12_3682
Secondary ID
Status Completed
Phase N/A
First received August 31, 2016
Last updated September 7, 2016
Start date October 2013
Est. completion date August 2016

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate in a multicentric cluster randomized study the effect of the presence of dedicated nurses for training of ICU staff in preventing nosocomial infections. The rate of bloodstream infections per 100 admitted patients is used as the main endpoint. A sample of 4000 included patients in the 6 participating ICU is included with the objective to show a reduction of one third of the rate of ICU-acquired bloodstream infections. The study is currently at the end of the recrutimeent phase.


Description:

15% of patients admitted to intensive care have an infection acquired in the service, including bacteremia is a serious form. Compliance with hygiene measures and recommendations in the use of invasive devices can reduce the incidence. The advantage of simple recommendations type "bundle" could, however, be insufficient because not associated with training and monitoring compliance with the recommendations. The aim of this study is to show that the daily intervention of a public health nurse on the basis of a half full-time equivalent, allows these actions and therefore a reduction in the bloodstream of the attack rate acquired in the ICU compared dissemination of simple recommendations.


Recruitment information / eligibility

Status Completed
Enrollment 4000
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- patients admitted to reanimation department

Exclusion Criteria:

- no exclusion criteria

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
hygienist response
The daily presence of a public health nurse in the intensive care unit would implement such a strategy for prevention of infections and reduce the incidence of bloodstream infections acquired in intensive care.

Locations

Country Name City State
France Hopital Nord Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of first ICU acquired bloodstream infection for 100 admitted patients Collection of blood cultures 2 months No