Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
Campylo-BJI
Campylo-BJI
Sponsor study identifier
observational
200
1 country
1
Study Start
January 1, 2024
Actual (reported)Primary Completion
April 1, 2024
Actual (reported)Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2024
Actual (reported)April 1, 2024
Actual (reported)May 17, 2024
Actual (reported)May 22, 2024
Actual (reported)June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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 .
Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy)
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
Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022
Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse
Lyon, 69317, France
First Submitted
May 17, 2024
First Posted
May 22, 2024
Study Start
January 1, 2024
Actual (reported)Primary Completion
April 1, 2024
Actual (reported)Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Completion
June 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 22, 2024
Record last verified: 2024-05
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Source: ClinicalTrials.gov.
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