Patients Hospitalized in Infectious Disease Clinical Trial
— ISOL/STANDOfficial title:
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.
| Status | Terminated |
| Enrollment | 400 |
| Est. completion date | June 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Crossover, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Rennes University Hospital | Rennes | Brittany |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Number of infections acquired during hospitalization in each group | 2 years | No | |
| Secondary | Consumption of hydro-alcoholic rub in each group | 2 years | No | |
| Secondary | Utilization of aprons and gloves in each group | 2 years | No |