Patients Hospitalized in Infectious DiseaseISOL/STANDNCT01562769
Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes
An observational study of Patients Hospitalized in Infectious Disease, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Hospitalized in Infectious Disease
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in Infectious Disease Unit of university-affiliated hospital in Rennes
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Number of infections acquired during hospitalization in each group
Measured: 2 years
Consumption of hydro-alcoholic rub in each group
Measured: 2 years
Utilization of aprons and gloves in each group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2015
- Study completionJun 2015
Why it stopped: enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalized in Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jean-marc chapplain, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562769
- Sponsor's protocol ID
- 2011-A01360-41
- Other IDs
- LOC/11-20
- Acronym
- ISOL/STAND
- Status last verified
- May 2015
- First submitted
- 22 Mar 2012
- Last updated
- 21 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes
- ClinicalTrials.gov ID
- NCT01562769
- Acronym / sponsor ID
- ISOL/STAND / 2011-A01360-41
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: enrollment difficulties
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in Infectious Disease Unit of university-affiliated hospital in Rennes
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study was stopped early (reason given: enrollment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean-marc chapplain principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Hospitalized in Infectious Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition rate of micro-organisms (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.