Implant-Associated P. Aeruginosa Bone And Joint Infections : Experience In A Regional Reference Center In France

August 10, 2018 updated by: Eugénie MABRUT, Hospices Civils de Lyon
The aim of this study is to describe the bone or joint infection due to Pseudomonas aeruginosa in patients having implant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • patients having BJI on implant caused by Pseudomonas aeruginosa

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Description of bone or joint infection on implant due to Pseudomonas aeruginosa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description and rate of bone or joint infection on implant caused due to Pseudomonas aeruginosa
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse events occurring under medical treatment against Pseudomonas aeruginosa
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
description of adverse events occurring under medical treatment against Pseudomonas aeruginosa in BJI
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Rate of Treatment Failure
Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)
Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin
Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (ACTUAL)

August 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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