OsteoArticular Sepsis in Intensive Care unitS

NCT06627842 | Recruiting

• 1 other identifier: APHP241174
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarticular Infection; Intensive Care Patients; Prosthetic Joint Infection

Keywords

Osteoarticular sepsis; sepsis; osteoarticular prothetis; intensive care; critical care; prosthetic joint infection

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• 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

Study Arms (1)

Global cohort

All patients admitted to intensive care during the study period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical care patients (intensive care and continuing care), admitted between 2018 and 2022 with a principal or associated diagnosis of prosthetic joint infection.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Lariboisière

Paris, France, 75010, France

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carine PARE

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Benjamin SOYER, MD, Msc

CONTACT

+33 1 49 95 85 15; benjamin.soyer@aphp.fr

Benjamin G CHOUSTERMAN, MD, PhD

CONTACT

benjamin.chousterman@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 4, 2024
• Study Start: March 31, 2025
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)