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

This study is currently recruiting participants.
Verified January 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01562769
First received: March 22, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.


Condition
Patients Hospitalized in Infectious Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Acquisition rate of micro-organisms [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Acquisition rate using bacteriological sampling (nose and anus) at admission and at the day of discharge in each patient hospitalized in the department.


Secondary Outcome Measures:
  • Number of infections acquired during hospitalization in each group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Consumption of hydro-alcoholic rub in each group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Utilization of aprons and gloves in each group [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562769

Contacts
Contact: jean-marc chapplain jean-marc.chapplain@chu-rennes.fr

Locations
France
Rennes University Hospital Recruiting
Rennes, Brittany, France, 35033
Contact: jean-marc chapplain    33-2-9928-9564    jean-marc.chapplain@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: jean-marc chapplain Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01562769     History of Changes
Other Study ID Numbers: 2011-A01360-41, LOC/11-20
Study First Received: March 22, 2012
Last Updated: January 9, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Additional relevant MeSH terms:
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on April 15, 2014