Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes (ISOL/STAND)
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| ClinicalTrials.gov Identifier: NCT01562769 |
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Recruitment Status :
Terminated
(enrollment difficulties)
First Posted : March 26, 2012
Last Update Posted : August 21, 2015
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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 |
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| 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 |
| Group/Cohort |
|---|
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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). |
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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). |
- 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.
- Number of infections acquired during hospitalization in each group [ Time Frame: 2 years ]
- Consumption of hydro-alcoholic rub in each group [ Time Frame: 2 years ]
- Utilization of aprons and gloves in each group [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
| France | |
| Rennes University Hospital | |
| Rennes, Brittany, France, 35033 | |
| Principal Investigator: | jean-marc chapplain | Rennes University Hospital |
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01562769 |
| 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 |
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Communicable Diseases Infection |