Tedizolid Suppressive Antimicrobial Therapy in a Reference Center (TediSAT)

Tedizolid Suppressive Antimicrobial Therapy

the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.

Study Overview

• Status: Completed
• Conditions: Bone and Joint Infection
• Intervention / Treatment: Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy managed at the CRIOAc LYON, Croix-Rousse Hospital

Description

Inclusion Criteria:

• patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy	Other: patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy; description of osteo-articular infection managed with tedizolid as a suppressive antibiotic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy	proportion of patients having tedizolid as a suppressive antibiotic therapy	between 2016 and 2021
rate of failure in patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic	proportion of patients having a failure under tedizolid as a suppressive antibiotic therapy	2 years
rate of adverse event in patients having had a BJI/PJI treated with tedizolid as a suppressive	proportion of patients having a adverse event under tedizolid as a suppressive antibiotic therapy	through study completion, an average of 1 year
Description of patients having had a BJI/PJI treated with tedizolid as a suppressive	type of patients: age, CMI, comorbidities...	2 years
Description of BJI/PJI treated with tedizolid as a suppressive	implant or prothese or not, acute/ chronic, bacteriology	2 years

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: bone and joint infection; tedizolid; suppressive antibiotic therapy
• Additional Relevant MeSH Terms: Infections; Anti-Infective Agents; Anti-Bacterial Agents; Tedizolid
• Other Study ID Numbers: 232

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