Osteoarticular InfectionOASISNCT06627842
OsteoArticular Sepsis in Intensive Care unitS
An observational study of Osteoarticular Infection and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarticular Infection, Intensive Care Patients, Prosthetic Joint Infection
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France
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.
- Keywords
- Osteoarticular sepsis, sepsis, osteoarticular prothetis, intensive care, critical care, prosthetic joint infection
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Global cohort | All patients admitted to intensive care during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Composite endpoint reflecting poor clinical outcome
- Mortality, measured in critical care, at 30 days, 1 year and 2 years
- Therapeutic failure at 2 years, defined as mechanical or septic failure.
- Functional failure at 2 years, defined as failure to resume walking and usual activities, to return home, or to regain autonomy.
Measured: 2 years
Mortality at 2 years
Measured: 2 years
Description of pathogens found in intraoperative samples, and their resistance spectrum
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start31 Mar 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Why it stopped: Temporary suspended. Wait for IRB approval (inclusion duration modified)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarticular InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine PARE, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627842
- Sponsor's protocol ID
- APHP241174
- Acronym
- OASIS
- Status last verified
- May 2026
- First submitted
- 3 Oct 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OSTEOARTICULAR SEPSIS ON EQUIPMENT in Intensive Care and Continuing Care Units in France
- ClinicalTrials.gov ID
- NCT06627842
- Acronym / sponsor ID
- OASIS / APHP241174
- Keywords
- Osteoarticular sepsis, sepsis, osteoarticular prothetis, intensive care, critical care, prosthetic joint infection
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Temporary suspended. Wait for IRB approval (inclusion duration modified)
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Global cohort | – | –All patients admitted to intensive care during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Composite endpoint reflecting poor clinical outcome
Time frame: 2 years
Mortality at 2 years
Time frame: 2 years
Description of pathogens found in intraoperative samples, and their resistance spectrum
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarticular Infection
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All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular Brucellosis
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RecruitingObservational study
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
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Population Pharmacokinetic Model of Rifampicin in Staphylococcal Osteoarticular Infections
Prosthetic Joint Infection, Osteomyelitis
Not yet recruitingPhase 3
Enhancing Amoxicillin Pharmacokinetics and Pharmacodynamics Parameters With Probenecid in Bone and Joint Infections
Osteoarticular Infections (OAIs)
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine PARE study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarticular Infection and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.