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

NCT ID: NCT01562769

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-06-30

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.

Conditions

Patients Hospitalized in Infectious Disease

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

jean-marc chapplain

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, Brittany Region, France

Countries

France

Other Identifiers

LOC/11-20

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A01360-41

Identifier Type: -

Identifier Source: org_study_id