ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01562769
Recruitment Status : Terminated (enrollment difficulties)
First Posted : March 26, 2012
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

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 or disease
Patients Hospitalized in Infectious Disease

Study Type : Observational
Actual Enrollment : 400 participants
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
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).




Primary Outcome Measures :
  1. Acquisition rate of micro-organisms [ Time Frame: 2 years ]
    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 :
  1. Number of infections acquired during hospitalization in each group [ Time Frame: 2 years ]
  2. Consumption of hydro-alcoholic rub in each group [ Time Frame: 2 years ]
  3. Utilization of aprons and gloves in each group [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562769


Locations
France
Rennes University Hospital
Rennes, Brittany, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: jean-marc chapplain Rennes University Hospital

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01562769     History of Changes
Other Study ID Numbers: 2011-A01360-41
LOC/11-20 ( Other Identifier: Rennes University Hospital (Direction of Clinical Research) )
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Communicable Diseases
Infection