Bone and Joint InfectionCRISBONCT04625478
Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections
An observational study of Bone and Joint Infection and Staphylococcus, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Bone and Joint Infection, Staphylococcus
- What is being tested?
- Patients having had an osteo-articular infection with Stahylococcus
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 20 Dec 2021
- 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 to 95 years
- All sexes
- Adult, Older adult
Study population: patients having had an osteo-articular infection with Staphylococci managed at the Croix-Rousse Hospital
Who may be able to join
- patients having had an osteo-articular infection with Staphylococci
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI.
The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.
- Conditions
- Bone and Joint Infection, Staphylococcus
- Being tested
- Patients having had an osteo-articular infection with Stahylococcus
- Keywords
- Bone and Joint Infection, Staphylococcus, intracellulare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients having had an osteo-articular infection with StahylococcusOther
Immunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection
| Study group | Role | What they receive |
|---|---|---|
| Patients having had an osteo-articular infection with Stahylococcus | Patients having had an osteo-articular infection with Stahylococcus managed at the Croix Rousse hospital Receives: Other: Patients having had an osteo-articular infection with Stahylococcus |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of intracellular staphylococci
to explore if intracellular staphylococci can be observed on samples of patient having an osteo-articular infection with staphylococci
Measured: 2 months
rate of localisation of intracellular staphylococci
to explore where in what type of celles they can be observed on samples of patient having an osteo-articular infection with staphylococci
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Dec 2020
- Primary completion20 Sep 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone and Joint InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625478
- Sponsor's protocol ID
- 229
- Acronym
- CRISBO
- Status last verified
- Dec 2025
- First submitted
- 6 Nov 2020
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections
- ClinicalTrials.gov ID
- NCT04625478
- Acronym / sponsor ID
- CRISBO / 229
- Conditions
- Bone and Joint Infection, Staphylococcus
- Keywords
- Bone and Joint Infection, Staphylococcus, intracellulare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 12 Nov 2020 (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.
Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI.
The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients having had an osteo-articular infection with Stahylococcus | – | Other: Patients having had an osteo-articular infection with StahylococcusPatients having had an osteo-articular infection with Stahylococcus managed at the Croix Rousse hospital |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients having had an osteo-articular infection with Staphylococci managed at the Croix-Rousse Hospital
Key inclusion criteria (1 listed)
- patients having had an osteo-articular infection with Staphylococci
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Patients having had an osteo-articular infection with StahylococcusImmunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection | Other | Patients having had an osteo-articular infection with Stahylococcus |
Primary outcome
detection of intracellular staphylococci
Time frame: 2 months
to explore if intracellular staphylococci can be observed on samples of patient having an osteo-articular infection with staphylococci
rate of localisation of intracellular staphylococci
Time frame: 2 months
to explore where in what type of celles they can be observed on samples of patient having an osteo-articular infection with staphylococci
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 19 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Bone and Joint Infection and Staphylococcus, run by Hospices Civils de Lyon 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 19 Dec 2025. 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?
detection of intracellular staphylococci (time frame: 2 months). The study lists 2 primary outcomes in all. 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 19 Dec 2025.