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

Campylobacter Infections Clinical Trial

— Campylo-BJI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425250
• Other study ID #: 69HCL23_5284
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Campylobacter Infections
• Communicable Diseases
• Infections

Intervention

Other:
• 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)
• 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

Locations

Country	Name	City	State
France	Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 .