MRSA BacteremiaNCT03096405
Impact MRSA -PCR on Patient Management
An observational study of MRSA Bacteremia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Bacteremia
- What is being tested?
- Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2014to 28 Feb 2017
- 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: every patient hospitalized in St Joseph Hospital with an positive hemoculture to Staphylococcus Aureus Methicillin Sensitive
Who may be able to join
- Hemoculture positive to Staphylococcus Aureus Methicillin Sensitive
Who cannot join
- Positive test to Staphylococcus Aureus Methicillin Sensitive but not hospitalized.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).
With the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.
The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.
- Conditions
- MRSA Bacteremia
- Being tested
- Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymerase Chain Reaction of Methicillin Resistant Staphyloccus AureusDiagnostic test
Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptation duration of antibiotherapy
Measured: 24 hours
Secondary outcomes (2)
Mortality
Measured: Day 30
average duration of hospitalization
Measured: day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start1 Feb 2014
- Primary completion31 Mar 2016
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA BacteremiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MIZRAHI Assaf, MD, Principal investigator, Groupe Hospitalier Paris St JOSEPHLEMONNIER Alban, MD, Study chair, Groupe Hospitalier Paris St JOSEPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096405
- Sponsor's protocol ID
- PCR-SARM
- Status last verified
- Mar 2017
- First submitted
- 25 Mar 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact MRSA -PCR on Patient Management
- ClinicalTrials.gov ID
- NCT03096405
- Acronym / sponsor ID
- PCR-SARM
- Conditions
- MRSA Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
Staphylococcus aureus represents one of the most met germs, with Escherichia coli, during bacteremia. Microbiologist distinguish at aureus S. two profiles of resistance in beta-lactamines: S. aureus sensitive to the methicillin ( SASM) and the S. aureus resistant to the methicillin ( SARM).
With the implementation of the MALDI-TOF, it is now possible to identify the origin responsible of the bacteremia the day of the positivity of the hemoculture ( J0) and to set up a treatment with adapted antibiotic, which, in the case of a sepsis to aureus S., is the vancomycine. Ye it was demonstrated, that the use of the vancomycine on the SASM increased the average duration of stay and a more important rate of relapse.
The PCR SARM was organized in the GHPSJ in 2014. It allows from the day of the positivity of the hemoculture ( J0), to determine the phenotype of resistance of S. aureus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- every patient hospitalized in St Joseph Hospital with an positive hemoculture to Staphylococcus Aureus Methicillin Sensitive
Key inclusion criteria (1 listed)
- Hemoculture positive to Staphylococcus Aureus Methicillin Sensitive
Key exclusion criteria (1 listed)
- Positive test to Staphylococcus Aureus Methicillin Sensitive but not hospitalized.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymerase Chain Reaction of Methicillin Resistant Staphyloccus AureusPolymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus | Diagnostic test | – |
Primary outcome
Adaptation duration of antibiotherapy
Time frame: 24 hours
2 secondary outcomes
Mortality
Time frame: Day 30
average duration of hospitalization
Time frame: day 30
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 30 May 2017.
- Individual participant dataSharing planned: No
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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.
MIZRAHI Assaf, MD principal investigator
Groupe Hospitalier Paris St JOSEPH
LEMONNIER Alban, MD study chair
Groupe Hospitalier Paris St JOSEPH
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 MRSA Bacteremia, run by Fondation Hôpital Saint-Joseph 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 30 May 2017. 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?
Adaptation duration of antibiotherapy (time frame: 24 hours). 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 30 May 2017.