Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes (ISOL/STAND)

Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious.

In a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest.

The investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.

Study Overview

• Status: Terminated
• Conditions: Patients Hospitalized in Infectious Disease

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Brittany
    • Rennes, Brittany, France, 35033
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Infectious Disease Unit of university-affiliated hospital in Rennes

Description

Inclusion Criteria:

• Patient hospitalized in Infectious Diseases Unit during the study period in one of the selected part of the unit participating to the study
• Patient informed about the study protocol and approved to participate.

Exclusion Criteria:

• Patient requiring isolation prescription type "air" or "droplet"
• Patient hospitalized in the central sector of the building (including 4 bedrooms in depression negative service)
• Patient colonized with bacteria producing carbapenemase, multi-resistant Acinetobacter baumanii or Vancomycin-Resistant Enterococcus.
• Patients under legal protection (juridical protection, legal guardianship) or persons on juridical detention.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard precautions; One selected part of the unit keep the usual procedure applied in our institution with contact precautions prescriptions when colonized patient is admitted with SA and/or ESBL bacteria. Second selected part of the unit applies only standard precautions (even for patients colonized with multiple drug-resistant organisms). After 8 months precaution procedures will be exchanged between the two sectors (cross over design).
contact precautions; One selected part of the unit keep the usual procedure applied in our institution with contact precautions prescriptions when colonized patient is admitted with SA and/or ESBL bacteria. Second selected part of the unit applies only standard precautions (even for patients colonized with multiple drug-resistant organisms). After 8 months precaution procedures will be exchanged between the two sectors (cross over design).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition rate of micro-organisms	Acquisition rate using bacteriological sampling (nose and anus) at admission and at the day of discharge in each patient hospitalized in the department.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of infections acquired during hospitalization in each group	2 years
Consumption of hydro-alcoholic rub in each group	2 years
Utilization of aprons and gloves in each group	2 years

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: jean-marc chapplain, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Estimate): August 21, 2015
• Last Update Submitted That Met QC Criteria: August 20, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2011-A01360-41; LOC/11-20 (Other Identifier: Rennes University Hospital (Direction of Clinical Research))