Retrospective Study of Bone Infection Due to Campylobacter Spp

NCT ID: NCT02884752

Last Updated: 2016-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Methods: By browsing the microbiological database of 6 BJI French reference centers, we collected all cases due to Campylobacter species between 2002 and 2012, including first and relapse cases. Clinical, microbiological and treatment features were analyzed using descriptive statistics.

Results: 14 episodes of BJI due to Campylobacter spp were identified in 10 patients. Mean age was 76.8 y.o. (63-96). Sex ratio M/F was 1.5. Nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. Immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). During the 10 primary cases: all patients had fever and 2 presented digestive symptoms. Campylobacter spp were isolated on per operative samples in 5 patients. One of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. Campylobacter species were C. fetus (n=7), C. coli (n=2) and C. spp (1). Strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). Only one C. fetus was susceptible to all antibiotics tested. Surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). The mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to C. fetus. All were resistant to more than one antibiotic classes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Campylobacter Infections Bone Diseases, Infectious

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient with peroperative bone samples positive to Campylobacter spp. between Jan 2002 and Dec. 2012
* Adults over 18 yo
* No opposition to the study expressed by the patient

Exclusion Criteria

* Adults below 18 yo
* Spine infection to Campylobacter spp.
* Outside of the timeframe of the study
* No microbiologic data available
* Opposition to the study expressed by the patient
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre de Référence des Infections Ostéo-Articulaires du Grand Ouest

UNKNOWN

Sponsor Role collaborator

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Séverine Ansart, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

CHU Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAMPYLO

Identifier Type: -

Identifier Source: org_study_id