Staphylococcus Aureus Nasal CarriageCONASA 398NCT03869255
Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings
An observational study of Staphylococcus Aureus Nasal Carriage, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus Nasal Carriage
- What is being tested?
- Nasal swab
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2019to Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: For community patients : All patients presenting for blood donation will be included For hospitalized patients, all patients hospitalized less than 48h in a service participating to the study will be enrolled
Who may be able to join
- the selection criteria for blood donation
- age ≥ 18 years old
- No refusal of the person
- age ≥ 18 years old
- hospitalization in one of the services participating in the study
- no refusal of the person
Who cannot join
- None
- For hospitalized patients :
- None
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.
Read the detailed description
Staphylococcus aureus (SA) is a ubiquitous bacterium, part of the human commensal flora. The mucosa of the anterior nasal cavities represents the preferred site of colonization of SA. The SA ST398 clone, belonging to CC 398, was initially described as a zoonotic agent initially identified in France and the Netherlands. In fact, ST398 strains are separated into two distinct populations: a methicillin-resistant SA population (SAMR) with notion of contact with animals and a more virulent methicillin-sensitive SA population (SAMS) than its counterpart, isolated from serious human infections and without notion of exposure to farm animals. Recently, we have shown that, in SA bacteremia, all strains of SA ST398 are sensitive to methicillin and that the prevalence of ST398 among all SAMS responsible for bacteremia at Besançon University Hospital increased between 2009 and 2014, increased from 4 to 15%. However, we were unable to study nasal colonization to support the mode of acquisition of SA ST398 (community vs. healthcare acquisition).
- Conditions
- Staphylococcus Aureus Nasal Carriage
- Being tested
- Nasal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swabProcedure or surgery
In hospitalized patiens, a nasal swab will be performed within the first 48 hours and on the 7th day. In community patient, only one swab will be performed
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized patients | Within 48 hours of admission to participating departments, all patiens will be included. A nasal swab will be performed within the first 48 hours and on the 7th day. Receives: Procedure: Nasal swab | |
| Community patients | People coming to donate blood in "Etablissement Français du Sang" will be included and a nasal swab will be performed Receives: Procedure: Nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients nasal carrying of SA ST398 strains in community and hospital settings
Number of patients with SA ST398 positive nasal swab in community will be compared with number of patients with SA ST398 positive nasal swab in hospital
Measured: One day
Secondary outcomes (3)
Number of patietns with specific Clinical and demographic data associated with nasal carrying of SA ST398
Clinical and demographic (sex, age, gender, comorbidities, tabaco...) data will be compared between patients with SA ST398 positive nasal swab and SA ST398 negative nasal swab
Measured: One day
Number of patients with SA ST398 positive nasal swab to seven days of hospitalization
Number of patients with SA ST398 positive nasal swab to seven days of hospitalization will be compared with the number of patients with SA ST398 positive nasal swab within the first 48 hours of hospitalization
Measured: 7 days
Number of virulence gene in SA ST 398 strains
Presence of virulence gene in SA ST 398 strains
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus Nasal CarriageStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869255
- Sponsor's protocol ID
- API/2018/96
- Acronym
- CONASA 398
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 11 Mar 2019
- 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 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Carrying by Staphylococcus Aureus ST398 Strains in Community and Hospital Settings
- ClinicalTrials.gov ID
- NCT03869255
- Acronym / sponsor ID
- CONASA 398 / API/2018/96
- Conditions
- Staphylococcus Aureus Nasal Carriage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 11 Mar 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 aim of this study was to compare the prevalence of nasal carrying of SA ST398 strains in community and hospital settings, identify the factors associated with colonization of SA ST398, determine the distribution of imported and acquired cases among SA ST398 hospital cases and characterize the genetic structure of the ST398 SA population involved in colonization.
Detailed description
Staphylococcus aureus (SA) is a ubiquitous bacterium, part of the human commensal flora. The mucosa of the anterior nasal cavities represents the preferred site of colonization of SA. The SA ST398 clone, belonging to CC 398, was initially described as a zoonotic agent initially identified in France and the Netherlands. In fact, ST398 strains are separated into two distinct populations: a methicillin-resistant SA population (SAMR) with notion of contact with animals and a more virulent methicillin-sensitive SA population (SAMS) than its counterpart, isolated from serious human infections and without notion of exposure to farm animals. Recently, we have shown that, in SA bacteremia, all strains of SA ST398 are sensitive to methicillin and that the prevalence of ST398 among all SAMS responsible for bacteremia at Besançon University Hospital increased between 2009 and 2014, increased from 4 to 15%. However, we were unable to study nasal colonization to support the mode of acquisition of SA ST398 (community vs. healthcare acquisition).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients | – | Procedure: Nasal swabWithin 48 hours of admission to participating departments, all patiens will be included. A nasal swab will be performed within the first 48 hours and on the 7th day. |
| Community patients | – | Procedure: Nasal swabPeople coming to donate blood in "Etablissement Français du Sang" will be included and a nasal swab will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For community patients : All patients presenting for blood donation will be included For hospitalized patients, all patients hospitalized less than 48h in a service participating to the study will be enrolled
Key inclusion criteria (6 listed)
- the selection criteria for blood donation
- age ≥ 18 years old
- No refusal of the person
- age ≥ 18 years old
- hospitalization in one of the services participating in the study
Key exclusion criteria (3 listed)
- None
- None
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 |
|---|---|---|
| Nasal swabIn hospitalized patiens, a nasal swab will be performed within the first 48 hours and on the 7th day. In community patient, only one swab will be performed | Procedure or surgery | Community patients, Hospitalized patients |
Primary outcome
Number of patients nasal carrying of SA ST398 strains in community and hospital settings
Time frame: One day
Number of patients with SA ST398 positive nasal swab in community will be compared with number of patients with SA ST398 positive nasal swab in hospital
3 secondary outcomes
Number of patietns with specific Clinical and demographic data associated with nasal carrying of SA ST398
Time frame: One day
Number of patients with SA ST398 positive nasal swab to seven days of hospitalization
Time frame: 7 days
Number of virulence gene in SA ST 398 strains
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nasal Carriage, run by Centre Hospitalier Universitaire de Besancon 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 6 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: status not confirmed, as of the sponsor's last update on 11 Mar 2019. 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?
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?
Number of patients nasal carrying of SA ST398 strains in community and hospital settings (time frame: One day). 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 11 Mar 2019.