Staphylococcus AureusPROSACNCT03833102
Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections
An observational study of Staphylococcus Aureus, run by Rennes University Hospital at 1 site in France.
Trial summary
The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is correlated to the RNA III and SprD RNAs expression Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- biological analysis
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2018to 22 Feb 2023
- 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: adult patients hospitalized S. aureus colonized or with SAB
Who may be able to join
- Patient over 18 years of age;
- Patients hospitalized at the University Hospital of Rennes, with according to groups:
- : Colonized subjects:
- Any patient hospitalized at the University Hospital of Rennes, or any health professional, in whom a colonization screening with S. aureus is performed in routine care and a colonization with S. aureus is documented;
- (For information, this screening is carried out frequently at the University Hospital of Rennes for different reasons (before surgery or procedure requiring the installation of equipment, screening of contact cases of infected cases, investigation during a nosocomial epidemic...). These people are hospitalized for reasons other than S. aureus infection and in different departments, but the samples are collected centrally in the institution's bacteriology laboratory.)
- : Patients hospitalized for BSA:
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- Patients hospitalized in the infectious diseases and medical intensive care unit and in the surgical intensive care unit, for whom a BSA is documented at the bacteriology laboratory of the University Hospital of Rennes;
- Patients for whom nasal carrying screening for S. aureus is prescribed as part of their management;
- These patients will be classified into two groups:
- Serious clinic (CG):
- BSA ;
- Associated with signs of sepsis according to the 20168 international definition:
- SOFA score (see Appendix 3) 2 ;
- Septic shock will be defined as the existence of sepsis associated with persistent low blood pressure requiring the administration of vasopressors to obtain an average blood pressure (MAP) 65 mmHg and an arterial lactate dosage 2 mmol/L despite adequate vascular filling.
- 2) Non-serious clinic (CNG):
- BSA ;
- Which does not meet the definition of the CG group.
- Having expressed their opposition to this research or whose trusted person does not oppose the research if the patient is not able to give an informed opinion.
Who cannot join
- Pregnant or breastfeeding women;
- Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty;
- S. aureus strain producing leucocidin from Panton-Valentine;
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is correlated to the RNA III and SprD RNAs expression
Read the detailed description
Staphylococcus aureus ranks among the top three organisms for community-acquired, healthcare-related and nosocomial infections in humans. It lives as a commensal organism but can also provoke very severe diseases. Identifying markers of the 'colonization/disease' transition is of paramount importance. We recently found that an association of two regulatory RNAs was associated with S. aureus infection rather than colonization and with the severity of infection. Those preliminary results have to be confirmed with a more important prospective cohort.
- Conditions
- Staphylococcus Aureus
- Being tested
- biological analysis
- Keywords
- Staphylococcus aureus
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological analysisOther
ST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction.
| Study group | Role | What they receive |
|---|---|---|
| Colonized patients' group (CPG) | all adult patients hospitalized in or consulting the Rennes University Hospital, known as S. aureus colonized could be included. In our institution, S. aureus colonization in the nostrils is screened in all patients supposed to undergo neurosurgical or orthopedic surgery. Receives: Other: biological analysis | |
| SAB patients' group (SAB) | all adult patients with SAB could be included. S. aureus colonization in the nostrils will be systematically screened immediately after the first result of positive S. aureus blood culture. Two subgroups will be individualized depending on the SOFA Score:
* Severe patients
* Non-severe patients Receives: Other: biological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia
Levels of expression of RNAIII and sprD in isolated strains of S. aureus isolated from bacteremia, compared to these same levels of expression in strains from colonized, uninfected patients.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start21 Feb 2018
- Primary completion22 Nov 2022
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu REVEST, Principal investigator, Centre Hospitalier Universitairede Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833102
- Sponsor's protocol ID
- 35RC17_9726_PROSAC
- Acronym
- PROSAC
- Status last verified
- Apr 2023
- First submitted
- 5 Feb 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Staphylococcus Aureus Clinical Isolates Versus Colonization: RNAs as Potential Biomarkers for Bloodstream Infections
- ClinicalTrials.gov ID
- NCT03833102
- Acronym / sponsor ID
- PROSAC / 35RC17_9726_PROSAC
- Conditions
- Staphylococcus Aureus
- Keywords
- Staphylococcus aureus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 6 Feb 2019 (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.
The primary objective is to demonstrate that the risk of S. aureus bacteremia (SAB) is correlated to the RNA III and SprD RNAs expression
Detailed description
Staphylococcus aureus ranks among the top three organisms for community-acquired, healthcare-related and nosocomial infections in humans. It lives as a commensal organism but can also provoke very severe diseases. Identifying markers of the 'colonization/disease' transition is of paramount importance. We recently found that an association of two regulatory RNAs was associated with S. aureus infection rather than colonization and with the severity of infection. Those preliminary results have to be confirmed with a more important prospective cohort.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonized patients' group (CPG) | – | Other: biological analysisall adult patients hospitalized in or consulting the Rennes University Hospital, known as S. aureus colonized could be included. In our institution, S. aureus colonization in the nostrils is screened in all patients supposed to undergo neurosurgical or orthopedic surgery. |
| SAB patients' group (SAB) | – | Other: biological analysisall adult patients with SAB could be included. S. aureus colonization in the nostrils will be systematically screened immediately after the first result of positive S. aureus blood culture. Two subgroups will be individualized depending on the SOFA Score: * Severe patients * Non-severe patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients hospitalized S. aureus colonized or with SAB
Key inclusion criteria (18 listed)
- Patient over 18 years of age;
- Patients hospitalized at the University Hospital of Rennes, with according to groups:
- (For information, this screening is carried out frequently at the University Hospital of Rennes for different reasons (before surgery or procedure requiring the installation of equipment, screening of contact cases of infected cases, investigation during a nosocomial epidemic...). These people are hospitalized for reasons other than S. aureus infection and in different departments, but the samples are collected centrally in the institution's bacteriology laboratory.)
- BSA ;
- Associated with signs of sepsis according to the 20168 international definition:
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding women;
- Persons of full age who are subject to legal protection (protection of justice, guardianship, guardianship), persons deprived of their liberty;
- S. aureus strain producing leucocidin from Panton-Valentine;
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 |
|---|---|---|
| biological analysisST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction. | Other | Colonized patients' group (CPG), SAB patients' group (SAB) |
Primary outcome
Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia
Time frame: through study completion, an average of 1 year
Levels of expression of RNAIII and sprD in isolated strains of S. aureus isolated from bacteremia, compared to these same levels of expression in strains from colonized, uninfected patients.
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 12 Apr 2023.
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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.
Matthieu REVEST principal investigator
Centre Hospitalier Universitairede Rennes
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 Staphylococcus Aureus, 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 18 inclusion and 3 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 12 Apr 2023. 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?
Levels of RNAIII expression and sprD in isolated strains of S. aureus from bacteremia (time frame: through study completion, an average of 1 year). 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 12 Apr 2023.