ArthritisSYNOLACTATES +NCT03819855
External Validation of a Septic Arthritis Prognosis Score
An observational study of Arthritis, run by Rennes University Hospital at 1 site in France.
Trial summary
Observational study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2019to 15 Feb 2021
- 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: Patients performing joint puncture in routine care as part of a diagnostic assessment of acute arthritis
Who may be able to join
- Any acute arthritis less than or equal to 30 days;
- Achievement of a joint puncture in routine care as part of the diagnostic assessment of this acute arthritis;
- Affiliation to a social security scheme;
- No one opposes his participation in the research.
Who cannot join
- Age below 18 years;
- Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days
Observational study
Read the detailed description
Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a prevalence of about 10% in front of an acute arthritis table sent to an emergency department.
The diagnosis is based on the bacteriological culture which finds the presence of a microorganism within the joint. However, only 80% of septic arthritis is bacteriologically documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially untimely antibiotherapy prior to joint puncture.
In addition, the bacteriological culture takes an average of 3 days to become positive, which may delay the implementation of appropriate antibiotic therapy.
It is therefore essential that the clinician can rely on other clinical or biological parameters, reliable and fast for better diagnostic orientation.
A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial lactate for the diagnosis of septic arthritis with very good performances. A RESAS score (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood of septic arthritis.
- Conditions
- Arthritis
- Medical subject headings
- Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
RESAS (Rennes Septic Arthritis Score)
Composite score of 4 biological variables of the synovial liquid (macroscopically purulent liquid and/or Synovial White Cells Counts (SWCC) ≥ 75000/mm3, synovial crystal vizualization, synovial lactate dosage, synovial glucose dosage). Each variable is weighted as follows: macroscopically purulent liquid or SWCC ≥ 75000/mm3 (+3 points), UMS (-4 points) or CPP (-2 points) crystal Vizualization, lactate ≥ 11.5 mmol/L (+6 points) or 10-11.4 mmol/L (+4 points) or 8.5-9.9 mmol/L (+2 points), glucose ≤ 1.0 mmol/L (+4 points), 1.1-1.8 mmol/L (+2 points), yielding a total between -4 and 13.
Measured: Up to 3 days (time to collect laboratory results)
Secondary outcomes (14)
Macroscopic synovial fluid appearance
Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads
Measured: Up to 1 day (time to collect clinical parameters)
Microscopic synovial analysis
Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)
Measured: Up to 3 days (time to collect laboratory results)
Synovial White Cells Count (SWCC)
Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)
Measured: Up to 3 days (time to collect laboratory results)
Total lactates, D-lactate, glucose
Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)
Measured: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Measures of CRP (mg/L) in synovial fluid
Measured: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Measures of Procalcitonine (ng/mL) in synovial fluid
Measured: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Measures of Calprotectin (ng/mL) in synovial fluid
Measured: Up to 3 days (time to collect laboratory results)
Multielemental analysis by ICP-MS
Screening multielemental in synovial fluid
Measured: Up to 3 days (time to collect laboratory results)
Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
Fever (expressed in Celcius degree)
Measured: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
Duration of symptoms (expressed in day)
Measured: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
Co-morbidity promoting infection (diabetes, cirrhosis, HIV, severe chronic renal failure, rheumatoid arthritis, other inflammatory rheumatic diseases, immunosuppressive treatments such as corticosteroids, conventional synthetic-DMARDs, biological-DMARDs) (Yes or No)
Measured: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
Number of joints affected (Ordinal variable)
Measured: Up to 1 day (time to collect clinical parameters)
Parameters that may influence the bacteriological results of synovial fluid
NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)
Measured: Up to 1 day (time to collect clinical parameters)
Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance
Measured: Date of hospitalization until 2 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start12 Mar 2019
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Coiffier, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819855
- Sponsor's protocol ID
- 35RC18_30015_SYNOLACTATES-PLUS
- Acronym
- SYNOLACTATES +
- Status last verified
- Mar 2021
- First submitted
- 11 Jan 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of the RESAS (REnnes Septic Arthritis Score) Septic Arthritis Prognosis Score in an Acute Arthritis Cohort of Less Than 30 Days
- ClinicalTrials.gov ID
- NCT03819855
- Acronym / sponsor ID
- SYNOLACTATES + / 35RC18_30015_SYNOLACTATES-PLUS
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 29 Jan 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.
Observational study
Detailed description
Septic arthritis is a diagnostic emergency for acute arthritis because it is accompanied by an excess of mortality of 11% and frequent functional sequelae in about 50% of cases in the year. However, it remains rare with an estimated annual incidence of 1 to 5/100000, and a prevalence of about 10% in front of an acute arthritis table sent to an emergency department.
The diagnosis is based on the bacteriological culture which finds the presence of a microorganism within the joint. However, only 80% of septic arthritis is bacteriologically documented due to low inoculum, the presence of fragile bacteria (Neisseria sp) or especially untimely antibiotherapy prior to joint puncture.
In addition, the bacteriological culture takes an average of 3 days to become positive, which may delay the implementation of appropriate antibiotic therapy.
It is therefore essential that the clinician can rely on other clinical or biological parameters, reliable and fast for better diagnostic orientation.
A first study: SYNOLACTATES showed the interest of the measurement of glucose and synovial lactate for the diagnosis of septic arthritis with very good performances. A RESAS score (REnnes Septic Arthritis Score) was constructed from these results to assess the likelihood of septic arthritis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients performing joint puncture in routine care as part of a diagnostic assessment of acute arthritis
Key inclusion criteria (4 listed)
- Any acute arthritis less than or equal to 30 days;
- Achievement of a joint puncture in routine care as part of the diagnostic assessment of this acute arthritis;
- Affiliation to a social security scheme;
- No one opposes his participation in the research.
Key exclusion criteria (2 listed)
- Age below 18 years;
- Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
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
RESAS (Rennes Septic Arthritis Score)
Time frame: Up to 3 days (time to collect laboratory results)
Composite score of 4 biological variables of the synovial liquid (macroscopically purulent liquid and/or Synovial White Cells Counts (SWCC) ≥ 75000/mm3, synovial crystal vizualization, synovial lactate dosage, synovial glucose dosage). Each variable is weighted as follows: macroscopically purulent liquid or SWCC ≥ 75000/mm3 (+3 points), UMS (-4 points) or CPP (-2 points) crystal Vizualization, lactate ≥ 11.5 mmol/L (+6 points) or 10-11.4 mmol/L (+4 points) or 8.5-9.9 mmol/L (+2 points), glucose ≤ 1.0 mmol/L (+4 points), 1.1-1.8 mmol/L (+2 points), yielding a total between -4 and 13.
14 secondary outcomes
Macroscopic synovial fluid appearance
Time frame: Up to 1 day (time to collect clinical parameters)
Microscopic synovial analysis
Time frame: Up to 3 days (time to collect laboratory results)
Synovial White Cells Count (SWCC)
Time frame: Up to 3 days (time to collect laboratory results)
Total lactates, D-lactate, glucose
Time frame: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Time frame: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Time frame: Up to 3 days (time to collect laboratory results)
Others synovial proteic markers
Time frame: Up to 3 days (time to collect laboratory results)
Multielemental analysis by ICP-MS
Time frame: Up to 3 days (time to collect laboratory results)
Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
Time frame: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis
Time frame: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
Time frame: Up to 1 day (time to collect clinical parameters)
Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis
Time frame: Up to 1 day (time to collect clinical parameters)
Parameters that may influence the bacteriological results of synovial fluid
Time frame: Up to 1 day (time to collect clinical parameters)
Number of hospitalization potentially avoided by the early elimination of an arthritis diagnosis and their cost, from the point of view of illness insurance
Time frame: Date of hospitalization until 2 months of follow-up
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 3 Mar 2021.
Related trials for Arthritis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
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.
Guillaume Coiffier principal investigator
Rennes University Hospital
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 Arthritis, run by Rennes University Hospital 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 4 inclusion and 2 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 3 Mar 2021. 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?
RESAS (Rennes Septic Arthritis Score) (time frame: Up to 3 days (time to collect laboratory results)). 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 3 Mar 2021.