Campylobacter InfectionsCampylo-BJINCT06425250
Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
An observational study of Campylobacter Infections, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Campylobacter Infections
- What is being tested?
- Management, progression and risk factors for failure of BJI caused by Campylobacter spp. and Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
Who may be able to join
- > 18 years
- Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
- Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
- Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
- Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
- Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections
- Patient who was informed and did not object to participating in the study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
Lyon, 69317
Florent VALOUR, Dr, 04 72 07 11 07 ext. +33, florent.valour@chu-lyon.fr
About this study
Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.
- Conditions
- Campylobacter Infections
- Being tested
- Management, progression and risk factors for failure of BJI caused by Campylobacter spp., Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.
- Keywords
- Management, Risk factors, Campylobacter spp.
- Medical subject headings
- Campylobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management, progression and risk factors for failure of BJI caused by Campylobacter spp.Other
Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy)
Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.Other
Failure of treatment: defined according to a composite criterion bringing together
- persistence of the infection under treatment, and/or
- recurrence of the infection after stopping antibiotic therapy, and/or
- need for surgical revision for septic reasons more than 5 days after initial treatment, and/or
- superinfection, and/or
- definitive explantation of the material, and/or
- decision for suppressive antibiotic therapy, and/or
- amputation, and/or
- death linked to infection
| Study group | Role | What they receive |
|---|---|---|
| Management, progression and risk factors for failure of BJI caused by Campylobacter spp. | Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022 Receives: Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp.; Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.
Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death
Measured: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Campylobacter InfectionsStudies 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
- 200 participants (estimated)
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
- NCT06425250
- Sponsor's protocol ID
- 69HCL23_5284
- Acronym
- Campylo-BJI
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 2024
- 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06425250
- Acronym / sponsor ID
- Campylo-BJI / 69HCL23_5284
- Conditions
- Campylobacter Infections
- Keywords
- Management, Risk factors, Campylobacter spp.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 May 2024 (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.
Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management, progression and risk factors for failure of BJI caused by Campylobacter spp. | – | Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp., Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
Key inclusion criteria (7 listed)
- > 18 years
- Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:
- Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter
- Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter
- Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter
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 |
|---|---|---|
| Management, progression and risk factors for failure of BJI caused by Campylobacter spp.Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy) | Other | Management, progression and risk factors for failure of BJI caused by Campylobacter spp. |
| Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.Failure of treatment: defined according to a composite criterion bringing together * persistence of the infection under treatment, and/or * recurrence of the infection after stopping antibiotic therapy, and/or * need for surgical revision for septic reasons more than 5 days after initial treatment, and/or * superinfection, and/or * definitive explantation of the material, and/or * decision for suppressive antibiotic therapy, and/or * amputation, and/or * death linked to infection | Other | Management, progression and risk factors for failure of BJI caused by Campylobacter spp. |
Primary outcome
Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.
Time frame: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .
Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
Related trials for Campylobacter Infections
RecruitingObservational study
Mucosal and Microbiota Changes During Acute Campylobacteriosis
Irritable Bowel Syndrome
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.
Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
Lyon, France
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 Campylobacter Infections, 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 7 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: status not confirmed, as of the sponsor's last update on 22 May 2024. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure. (time frame: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .). 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 22 May 2024.