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

NCT06425250 | Recruiting

• 1 other identifier: 69HCL23_5284
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Campylobacter Infections

Keywords

Management; Risk factors; Campylobacter spp.

Outcome Measures

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

  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 .

Study Arms (1)

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

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)

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. 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

Management, progression and risk factors for failure of BJI caused by Campylobacter spp.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \> 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse

Lyon, 69317, France

RECRUITING

MeSH Terms

Conditions

Campylobacter Infections

Interventions

Therapeutics; Risk Factors

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: June 30, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

FR (1)