NCT02884752

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
Last Updated

August 31, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

August 26, 2016

Last Update Submit

August 26, 2016

Conditions

Campylobacter InfectionsBone Diseases, Infectious

Outcome Measures

Primary Outcomes (1)

  • Incidence rate of reported prosthetic joint Campylobacter spp. Infections

    1986 to 2013

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with peroperative bone samples positive to Campylobacter spp.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Campylobacter InfectionsBone Diseases, Infectious

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Séverine Ansart, MD, PHD

    CHU Brest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

August 31, 2016

Study Start

December 1, 2014

Primary Completion

December 1, 2014

Study Completion

July 1, 2015

Last Updated

August 31, 2016

Record last verified: 2016-07

Locations

FR(1)