Joint EffusionPRASEPTNCT03979937
Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion
An observational study of Joint Effusion and Septic Arthritis, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Effusion, Septic Arthritis, Arthritis
- What is being tested?
- Arthrocentesis
- Type of treatment
- Surgery or procedure
- How many people
- 328 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2020to 1 Mar 2022
- How long will I take part?
- 10 Days
- 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
- Adult, Older adult
Study population: All adult patients presenting with at least one clinical joint effusion accessible to arthrocentesis, interesting a native non operated joint, without any general antibiotic therapy in the previous 15 days.
Who may be able to join
- Adult patient (age ≥ 18 years)
- Hospitalized in the conventional hospitalization unit or day hospitalization unit or received in consultation within the Rheumatology or Infectious Diseases units at the Le Mans General Hospital
- presenting at least one joint effusion at clinical examination
- Interesting a native, nonoperated joint, accessible to a puncture based on clinical markers, determined by palpatory anatomy
- Affiliated to social security
- No opposition expressed after written information
Who cannot join
- General antibiotic therapy in progress or completed less than 15 days before
- Failure to perform the arthrocentesis
- Person subject to a legal protection measure, not allowing his compliance with the study
- Participant already included in another study (exclusivity clause)
Trial locations and contacts
1 site in 1 country.
About this study
Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.
Read the detailed description
In accordance with guidelines and because of the potential gravity that this situation could represent, any joint effusion must be considered as a septic arthritis until proven otherwise, thus justifying an arthrocentesis and an adequate treatment. Nevertheless, because of epidemiology in primary care, this pragmatic attitude is quite commonly obscured and practices vary according to the experience of the doctor and his personal habits. As a result, the arthrocentesis is not commonly performed and anti-inflammatory treatment, whether based on NSAIDs or corticosteroids, is even sometimes administered to the patient despite the contrary guidelines. Although usually effective, this attitude is however not without risks. In this context, it seems interesting to develop a simple, reproducible and applicable diagnostic tool in a primary care setting for predicting the risk of septic arthritis.
This study is therefore aimed at the development and validation of a predictive score based on simple clinical and paraclinical data (such as the macroscopic appearance of the synovial fluid removed) in a patient with an effusion, whatever either the clinical presentation, whether isolated or integrated in a more complex clinical presentation, whether associated with locoregional inflammatory or general signs or not.
- Conditions
- Joint Effusion, Septic Arthritis, Arthritis
- Being tested
- Arthrocentesis
- Medical subject headings
- Hydrarthrosis, Arthritis, Infectious, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthrocentesisProcedure or surgery
Arthrocentesis to determine the nature of the effusion (septic or aseptic).
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a septic arthritis
Presence of more than 2000 cells/mL and bacterial growth in the articular fluid.
Measured: 10 days after the arthrocentesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start15 Feb 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint EffusionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 328 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Dernis, MD, Principal investigator, Centre Hospitalier du Mans, Rheumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979937
- Sponsor's protocol ID
- CHM-2019/S7/03
- Acronym
- PRASEPT
- Status last verified
- Mar 2022
- First submitted
- 6 Jun 2019
- Last updated
- 9 Mar 2022
- 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 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion
- ClinicalTrials.gov ID
- NCT03979937
- Acronym / sponsor ID
- PRASEPT / CHM-2019/S7/03
- Conditions
- Joint Effusion, Septic Arthritis, Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Jun 2019 (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.
Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.
Detailed description
In accordance with guidelines and because of the potential gravity that this situation could represent, any joint effusion must be considered as a septic arthritis until proven otherwise, thus justifying an arthrocentesis and an adequate treatment. Nevertheless, because of epidemiology in primary care, this pragmatic attitude is quite commonly obscured and practices vary according to the experience of the doctor and his personal habits. As a result, the arthrocentesis is not commonly performed and anti-inflammatory treatment, whether based on NSAIDs or corticosteroids, is even sometimes administered to the patient despite the contrary guidelines. Although usually effective, this attitude is however not without risks. In this context, it seems interesting to develop a simple, reproducible and applicable diagnostic tool in a primary care setting for predicting the risk of septic arthritis.
This study is therefore aimed at the development and validation of a predictive score based on simple clinical and paraclinical data (such as the macroscopic appearance of the synovial fluid removed) in a patient with an effusion, whatever either the clinical presentation, whether isolated or integrated in a more complex clinical presentation, whether associated with locoregional inflammatory or general signs or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients presenting with at least one clinical joint effusion accessible to arthrocentesis, interesting a native non operated joint, without any general antibiotic therapy in the previous 15 days.
Key inclusion criteria (6 listed)
- Adult patient (age ≥ 18 years)
- Hospitalized in the conventional hospitalization unit or day hospitalization unit or received in consultation within the Rheumatology or Infectious Diseases units at the Le Mans General Hospital
- presenting at least one joint effusion at clinical examination
- Interesting a native, nonoperated joint, accessible to a puncture based on clinical markers, determined by palpatory anatomy
- Affiliated to social security
Key exclusion criteria (4 listed)
- General antibiotic therapy in progress or completed less than 15 days before
- Failure to perform the arthrocentesis
- Person subject to a legal protection measure, not allowing his compliance with the study
- Participant already included in another study (exclusivity clause)
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 |
|---|---|---|
| ArthrocentesisArthrocentesis to determine the nature of the effusion (septic or aseptic). | Procedure or surgery | – |
Primary outcome
Presence of a septic arthritis
Time frame: 10 days after the arthrocentesis.
Presence of more than 2000 cells/mL and bacterial growth in the articular fluid.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Emmanuelle Dernis, MD principal investigator
Centre Hospitalier du Mans, Rheumatology Department
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 Joint Effusion and Septic Arthritis, run by Centre Hospitalier le Mans 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 9 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of a septic arthritis (time frame: 10 days after the arthrocentesis.). 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 9 Mar 2022.