Prosthesis and Bone InfectionsCaBJINCT03950063
Cutibacterium Acnes in Bone and Joint Infections
An observational study of Prosthesis and Bone Infections and Cutibacterium Acnes, run by CHU de Reims at 1 site in France.
Trial summary
Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis and Bone Infections, Cutibacterium Acnes
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2019to 15 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Cutibacterium acnes bone infections
Who may be able to join
- bone infection with C. acnes,
- isolation of the strain,
- presence of a single species,
- conservation of a viable strain,
- patients over 18 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.
Read the detailed description
The aim of the study is to evaluate specific pathogenicity factors (ability to internalize bone cells and ability to form a biofilm) of bacteria derived from clinical strains of C. acnes isolated from bone infections on orthopedic material.
- Keywords
- Cutibacterium acnes Prosthesis, Bone Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cutibacterium acnes bone infections | Patients with Cutibacterium acnes orthopedic material infections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internalization capacity of C. acnes strains
- acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the bacteria will be co cultured with bone cells (osteoblast) and bacteria will be internalized by the bone cells. After killing bacteria stayed outside of the cells with an antibiotic and lysis of the cells, the number of bacteria internalized will be counted on agar plate.
Measured: Day 0
Biofilm capacity of C. acnes strains
- acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the biofilm biomass will be evaluated by Crystal violet staining. The amount of biofilm will be evaluated by absorbance (optic density by spectrophotometry).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start15 Jun 2019 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis and Bone InfectionsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950063
- Sponsor's protocol ID
- PA18027
- Acronym
- CaBJI
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Celine M, Jennifer VS, Xavier O, Baptiste F, Sophie G, Lukshe K, Fany R. Unraveling the Enigmatic Behavior of Cutibacterium acnes: Exploring Clinical Correlations and Behaviors of Clinical Strains in Prosthetic Joint Infections. Int J Microbiol. 2026 Mar 5;2026:8475639. doi: 10.1155/ijm/8475639. eCollection 2026.
PubMed 41798862
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutibacterium Acnes in Bone and Joint Infections
- ClinicalTrials.gov ID
- NCT03950063
- Acronym / sponsor ID
- CaBJI / PA18027
- Keywords
- Cutibacterium acnes Prosthesis, Bone Infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 15 May 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.
Prosthetic Joint Infections (PJIs) are increasing with the use of orthopedic devices on an ageing population. Cutibacterium acnes is a commensal organism that plays an important role in the ecosystem healthy human skin, yet this species is also recognized as a pathogen in foreign body infection: endocarditis, prostatitis and specifically in PJIs. C. acnes is able to escape the immune system. This phenomenon could reflect two bacterial behavior: the bacterial internalization by host cells and the biofilm formation.
Detailed description
The aim of the study is to evaluate specific pathogenicity factors (ability to internalize bone cells and ability to form a biofilm) of bacteria derived from clinical strains of C. acnes isolated from bone infections on orthopedic material.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cutibacterium acnes bone infections | – | –Patients with Cutibacterium acnes orthopedic material infections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Cutibacterium acnes bone infections
Key inclusion criteria (5 listed)
- bone infection with C. acnes,
- isolation of the strain,
- presence of a single species,
- conservation of a viable strain,
- patients over 18 years
Key exclusion criteria (0 listed)
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
Internalization capacity of C. acnes strains
Time frame: Day 0
C. acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the bacteria will be co cultured with bone cells (osteoblast) and bacteria will be internalized by the bone cells. After killing bacteria stayed outside of the cells with an antibiotic and lysis of the cells, the number of bacteria internalized will be counted on agar plate.
Biofilm capacity of C. acnes strains
Time frame: Day 0
C. acnes strains will be cultured for 5 days in rich medium at 37°C in anaerobic conditions. Then, the biofilm biomass will be evaluated by Crystal violet staining. The amount of biofilm will be evaluated by absorbance (optic density by spectrophotometry).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Derived from this study: PubMed 41798862Celine M, Jennifer VS, Xavier O, Baptiste F, Sophie G, Lukshe K, Fany R. Unraveling the Enigmatic Behavior of Cutibacterium acnes: Exploring Clinical Correlations and Behaviors of Clinical Strains in Prosthetic Joint Infections. Int J Microbiol. 2026 Mar 5;2026:8475639. doi: 10.1155/ijm/8475639. eCollection 2026.
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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.
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 Prosthesis and Bone Infections and Cutibacterium Acnes, run by CHU de Reims 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 5 inclusion and 0 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 15 May 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?
Contact Xavier OHL (03 26 78 32 72, xohl@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internalization capacity of C. acnes strains (time frame: Day 0). 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?
On the ClinicalTrials.gov record for NCT03950063, which also lists 1 linked publication.
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 15 May 2019.