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RecruitingNCT06425250Campylo-BJIUpdated May 22, 2024

Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study

An observational study in Campylobacter Infections, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years to 100 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Campylobacter Infections

Keywords

  • Management
  • Risk factors
  • Campylobacter spp.
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 200 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022

Inclusion criteria

  • > 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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    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.

Interventions

  • OtherManagement, 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)

  • OtherDescription 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

06

What researchers measure

Primary outcomes

  1. 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

    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 .

07

Study locations

1 of 1 sites recruiting
  • Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
    Lyon, 69317, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06425250
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
May 22, 2024
Start date
Jan 1, 2024
Primary completion
Apr 1, 2024
Completion
Jun 30, 2024 (estimated)
Last update
May 22, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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