Multi-drug Resistant BacteriaPSBMRNCT02890433
Standard Precautions Versus Contact Additional Precautions Against Multi-drug Resistant Bacteria in Intensive Care Unit (PSBMR)
An observational study of Multi-drug Resistant Bacteria, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multi-drug Resistant Bacteria
- How many people
- 3,124 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients hospitalized in the resuscitation unit of the study
Who may be able to join
- hospitalization in resuscitation unit
Who cannot join
- opposition for gathering data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Standard Precautions as Efficient as Contact Additional Precautions Against the Transmission of Multi-drug Resistant Bacteria in Intensive Care Unit ?
The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.
Read the detailed description
The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.
This study seeks showing it in way of a non-interventional research in a resuscitation unit. Two periods are compared for noticing the rates of MDR bacteria contaminations.
- Conditions
- Multi-drug Resistant Bacteria
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Meticillin Resistant Staphylococcus Aureus (MRSA) and Enterobacteriaceae producing Extended Spectrum Beta-Lactamase (EESBL) per 1000 hospitalization days
Measured: 1000 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-drug Resistant BacteriaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jocelyne SELLIES, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890433
- Sponsor's protocol ID
- 2015-06Obs-CHRMT
- Acronym
- PSBMR
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Standard Precautions as Efficient as Contact Additional Precautions Against the Transmission of Multi-drug Resistant Bacteria in Intensive Care Unit ?
- ClinicalTrials.gov ID
- NCT02890433
- Acronym / sponsor ID
- PSBMR / 2015-06Obs-CHRMT
- Conditions
- Multi-drug Resistant Bacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,124 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Sep 2016 (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.
The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.
Detailed description
The national recommendations promote the applying of the Contact Additional Precautions (CAP) with the Standard Precautions (SP) to limit the transmission of multi-drug resistant (MDR) bacteria. However, that could entail more costs and a reduction of quality of the patient care.
This study seeks showing it in way of a non-interventional research in a resuscitation unit. Two periods are compared for noticing the rates of MDR bacteria contaminations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients hospitalized in the resuscitation unit of the study
Key inclusion criteria (1 listed)
- hospitalization in resuscitation unit
Key exclusion criteria (1 listed)
- opposition for gathering data
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
Rate of Meticillin Resistant Staphylococcus Aureus (MRSA) and Enterobacteriaceae producing Extended Spectrum Beta-Lactamase (EESBL) per 1000 hospitalization days
Time frame: 1000 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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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.
Jocelyne SELLIES, MD principal investigator
CHR Metz-Thionville
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 Multi-drug Resistant Bacteria, run by Centre Hospitalier Régional Metz-Thionville 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Meticillin Resistant Staphylococcus Aureus (MRSA) and Enterobacteriaceae producing Extended Spectrum Beta-Lactamase (EESBL) per 1000 hospitalization days (time frame: 1000 days). 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 7 Sep 2016.