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Clinical Trials/NCT06627842
NCT06627842SuspendedNot Applicable

OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France

Assistance Publique - Hôpitaux de Paris1 site in 1 country150 target enrollmentStarted: March 31, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Enrollment
150
Locations
1
Primary Endpoint
The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.

Study Overview

Brief Summary

This is an ambispective observational study of patients admitted to intensive care with a diagnosis of joint prosthesis infection (mainly knee and hip prostheses). The main objective of the study is to describe the profile, care trajectories during the stay (before or after surgery) and prognosis of patients admitted to critical care with such an infection. We also aim to compare prognosis between different groups of patients sharing the same profile and care trajectory, and to assess independent risk factors associated with 2-year mortality among the study population. Finally, we will describe the microbiological and resistance profile of severe osteoarticular device infections requiring critical care admission in France.

This is a descriptive and analytical observational study open to all French public and private hospitals.

Patient data will be retrieved prospectively from patient source files. Only 2-year data (vital status, functional data) will be collected specifically for the study, by telephone contact with the patient or his or her support person.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient at least 18 years old.
  • •Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022 of at least 48 hours, with prosthetic joint infection (hip, knee or shoulder prosthesis infection) as the main or associated diagnosis.

Exclusion Criteria

  • •Infection on osteosynthesis material
  • •Infection on spinal equipment
  • •Patient with several infected prostheses
  • •Recurrence of infection on prosthesis with the same microorganism
  • •Patient opposing data collection
  • •Patient under legal protection.
  • •Pregnant or breast-feeding patient.
  • •Patient deprived of liberty.

Arms & Interventions

Global cohort

All patients admitted to intensive care during the study period

Outcomes

Primary Outcomes

The profile, trajectories of care during the stay (before or after surgery) and the prognosis of patients admitted to intensive care for joint prosthesis infection over a 2-year period after admission to intensive care.

Time Frame: 2 years

Secondary Outcomes

  • Composite endpoint reflecting poor clinical outcome(2 years)
  • Mortality at 2 years(2 years)
  • Description of pathogens found in intraoperative samples, and their resistance spectrum(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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