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 August 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01562769
First received: March 22, 2012
Last updated: August 9, 2012
Last verified: August 2012

March 22, 2012
August 9, 2012
March 2012
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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.
Same as current
Complete list of historical versions of study NCT01562769 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes
Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

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.

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Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

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

Patients Hospitalized in Infectious Disease
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  • 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).

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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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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.
Both
18 Years and older
No
Contact: jean-marc chapplain jean-marc.chapplain@chu-rennes.fr
France
 
NCT01562769
2011-A01360-41, LOC/11-20
Not Provided
Rennes University Hospital
Rennes University Hospital
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Principal Investigator: jean-marc chapplain Rennes University Hospital
Rennes University Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP