OsteoArticular Sepsis in Intensive Care unitS

NCT ID: NCT06627842

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarticular Infection Intensive Care Patients Prosthetic Joint Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Global cohort

All patients admitted to intensive care during the study period

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carine PARE

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital Lariboisière

Paris, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Benjamin SOYER, MD, Msc

Role: CONTACT

+33 1 49 95 85 15

Benjamin G CHOUSTERMAN, MD, PhD

Role: CONTACT

Facility Contacts

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SOYER

Role: primary

01.49.95.85.15

Other Identifiers

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APHP241174

Identifier Type: -

Identifier Source: org_study_id

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