Osteoarticular InfectionsOASIS²NCT07107685
Prosthetic Joint Infection : Lessons From Deceased Patients in Critical Care.
An observational study of Osteoarticular Infections and Intensive Care Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This is an observational, retrospective, multicenter study based on the use of demographic, clinical and biological data from deceased patients admitted between 2018 and 2022 to critical care with a principal or associated diagnosis of joint prosthesis infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarticular Infections, Intensive Care Patients, Prosthetic Joint Infection
- What is being tested?
- Global cohort
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 24 Sep 2025to 24 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 joint prosthesis infection, who have since died.
Who may be able to join
- Patient aged 18 years or older.
- Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022, lasting at least 48 hours, with a prosthetic joint infection (hip, knee, or shoulder prosthesis infection) as the primary or associated diagnosis.
- Deceased patient who had not refused data processing.
Who cannot join
- Infection involving osteosynthesis material
- Infection involving spinal instrumentation
- Patient with multiple infected prostheses
- Recurrence of prosthetic infection with the same microorganism as a previous episode
- Patient under legal protection
- Pregnant or breastfeeding patient
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Benjamin CHOUSTERMAN, MD, PhD contact
About this study
Official title: Osteoarticular Sepsis In Intensive Care Units : a Retrospective Study About Deceased Patients.
This is an observational, retrospective, multicenter study based on the use of demographic, clinical and biological data from deceased patients admitted between 2018 and 2022 to critical care with a principal or associated diagnosis of joint prosthesis infection.
Data from this study will be combined with that from the OASIS study (APHP241174/ ID-RCB: 2024-A01769-38) concerning osteoarticular sepsis on prosthetic material in critical care of living patients.
Read more
The aim of this study is to improve our knowledge of the profile, care trajectories and outcomes of patients hospitalized in critical care in the context of osteoarticular material sepsis.
The results of the study could help identify at-risk populations and improve management strategies for patients with osteoarticular sepsis.
- Being tested
- Global cohort
- 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.
Global cohortOther
All deceased patients admitted to intensive care during the study period and satisfying the eligibility criteria.
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological description of deceased patients
Demographic data, medical history, history of Periprosthetic Joint Infection (timing, diagnosis, surgery, antibiotics), data in intensive care unit (leng of stay, organ failure, drugs and mechanical support, biological data) and outcome (time of death within 2 years after admission to Intensive Care Units).
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
Epidemiological description based on the number (n) and proportion (%) of bacterial strains found in samples collected during the operation.
Special focus on: Gram-positive bacteria (Staphylococcus, Streptococcus, Enterococcus), Gram-negative bacteria (Enterobacteriacea, Pseudmononas), slow-growing bacteria (Cutibacterium, Corynenbacteria), yeasts; resistance mechanisms (meticillin, rifampicin, quinolone, glycopeptide, ESBL, carbapenem).
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 posted6 Aug 2025
- Study start24 Sep 2025
- Primary completion24 Sep 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarticular InfectionsStudies 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
- Retrospective
- 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
- NCT07107685
- Sponsor's protocol ID
- APHP250872
- Acronym
- OASIS²
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2025
- Last updated
- 1 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoarticular Sepsis In Intensive Care Units : a Retrospective Study About Deceased Patients.
- ClinicalTrials.gov ID
- NCT07107685
- Acronym / sponsor ID
- OASIS² / APHP250872
- Keywords
- Osteoarticular sepsis, sepsis, osteoarticular prothetis, intensive care, critical care, prosthetic joint infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 24 Sep 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 6 Aug 2025 (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 observational, retrospective, multicenter study based on the use of demographic, clinical and biological data from deceased patients admitted between 2018 and 2022 to critical care with a principal or associated diagnosis of joint prosthesis infection.
Data from this study will be combined with that from the OASIS study (APHP241174/ ID-RCB: 2024-A01769-38) concerning osteoarticular sepsis on prosthetic material in critical care of living patients.
The aim of this study is to improve our knowledge of the profile, care trajectories and outcomes of patients hospitalized in critical care in the context of osteoarticular material sepsis.
The results of the study could help identify at-risk populations and improve management strategies for patients with osteoarticular sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
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 joint prosthesis infection, who have since died.
Key inclusion criteria (3 listed)
- Patient aged 18 years or older.
- Hospitalization in critical care (intensive care unit or continuing care unit) between 2018 and 2022, lasting at least 48 hours, with a prosthetic joint infection (hip, knee, or shoulder prosthesis infection) as the primary or associated diagnosis.
- Deceased patient who had not refused data processing.
Key exclusion criteria (7 listed)
- Infection involving osteosynthesis material
- Infection involving spinal instrumentation
- Patient with multiple infected prostheses
- Recurrence of prosthetic infection with the same microorganism as a previous episode
- Patient under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global cohortAll deceased patients admitted to intensive care during the study period and satisfying the eligibility criteria. | Other | – |
Primary outcome
Epidemiological description of deceased patients
Time frame: 2 years
Demographic data, medical history, history of Periprosthetic Joint Infection (timing, diagnosis, surgery, antibiotics), data in intensive care unit (leng of stay, organ failure, drugs and mechanical support, biological data) and outcome (time of death within 2 years after admission to Intensive Care Units).
3 secondary outcomes
Composite endpoint reflecting poor clinical outcome
Time frame: 2 years
Mortality at 2 years
Time frame: 2 years
Epidemiological description based on the number (n) and proportion (%) of bacterial strains found in samples collected during the operation.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarticular Infections
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All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular Brucellosis
Brucellosis, Osteoarticular Brucellosis
RecruitingObservational study
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
Recruiting
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.
Benjamin CHOUSTERMAN, MD, PhD contact
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 Infections 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 1 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin SOYER, MD, Msc (+33 1 49 95 85 15, benjamin.soyer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological description of deceased patients (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 1 Jun 2026.