CClinicalTrials.gg
CompletedNCT02884752CAMPYLOUpdated Aug 31, 2016

Retrospective Study of Bone Infection Due to Campylobacter Spp

An observational study in Campylobacter Infections and Bone Diseases, Infectious, sponsored by University Hospital, Brest. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2016-08-31.

Sponsored by University Hospital, Brest · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
10
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Campylobacter Infections
  • Bone Diseases, Infectious
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with peroperative bone samples positive to Campylobacter spp.

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

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
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
10 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Incidence rate of reported prosthetic joint Campylobacter spp. Infections

    Time frame: 1986 to 2013

06

Study locations

1 site
  • CHRU de Brest
    Brest, 29609, France
07

Registry details

Key details

Study ID
NCT02884752
Lead sponsor
University Hospital, Brest
Collaborators
Centre de Référence des Infections Ostéo-Articulaires du Grand Ouest
Responsible party
Sponsor
First posted
Aug 31, 2016
Start date
Dec 2014
Primary completion
Dec 2014
Completion
Jul 2015
Last update
Aug 31, 2016

Study contacts

Séverine Ansart, MD, PHD
principal investigator · CHU Brest

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion