NCT03624855

Brief Summary

The aim of this study is to describe the bone or joint infection due to Pseudomonas aeruginosa in patients having implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

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

March 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

August 6, 2018

Last Update Submit

August 10, 2018

Conditions

Bone and Joint Infection

Outcome Measures

Primary Outcomes (1)

  • Description and rate of bone or joint infection on implant caused due to Pseudomonas aeruginosa

    Description of the type of infection due to P. aeruginosa : patients and type of implant, profile of the bacterium, medical and chirurgical treatment, rate

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Secondary Outcomes (2)

  • Rate of adverse events occurring under medical treatment against Pseudomonas aeruginosa

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

  • Rate of Treatment Failure

    Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Study Arms (1)

Description of BJI due to Pseudomonas aeruginosa

patients having bone and joint infection on implant due to Pseudomonas aeruginosa

Other: Bone or joint infection due to Pseudomonas aeruginosa

Interventions

Bone or joint infection due to Pseudomonas aeruginosaOTHER

Description of bone or joint infection on implant due to Pseudomonas aeruginosa

Description of BJI due to Pseudomonas aeruginosa

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients having BJI on implant caused by Pseudomonas aeruginosa managed at the Croix Rousse Hospital

You may qualify if:

  • patients having BJI on implant caused by Pseudomonas aeruginosa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69004, France

Location

Study Officials

  • Tristan FERRY, Md,PhD

    Hospices Civils de Lyon Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Assistant

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 10, 2018

Study Start

March 1, 2018

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

FR(1)