Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

External Validation of a Septic Arthritis Prognosis Score (SYNOLACTATES +)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819855
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Observational study

Condition or disease
Arthritis

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Macroscopic synovial fluid appearance [ Time Frame: Up to 1 day (time to collect clinical parameters) ]
    Expressed in multiple qualitative variable: purulent, trouble, clear citrine appearance, hemarthrosis or clear with blood threads

  2. Microscopic synovial analysis [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Presence of crystals in synovial fluid: urate monosodic (UMS) crystal (Yes or No), and calcium pyrophosphate crystal (CPP) (Yes or No)

  3. Synovial White Cells Count (SWCC) [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Number (n) of White cells in synovial fluid. (quantitative variable expressed in n/mm3)

  4. Total lactates, D-lactate, glucose [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Measures of total lactate, D-lactate et glucose in synovial fluid (quantitative variable expressed in mmol/L)

  5. Others synovial proteic markers [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Measures of CRP (mg/L) in synovial fluid

  6. Others synovial proteic markers [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Measures of Procalcitonine (ng/mL) in synovial fluid

  7. Others synovial proteic markers [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Measures of Calprotectin (ng/mL) in synovial fluid

  8. Multielemental analysis by ICP-MS [ Time Frame: Up to 3 days (time to collect laboratory results) ]
    Screening multielemental in synovial fluid

  9. Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis [ Time Frame: Up to 1 day (time to collect clinical parameters) ]
    Fever (expressed in Celcius degree)

  10. Number of classical clinical marker (quantitative variable) to diagnosis of septic arthritis [ Time Frame: Up to 1 day (time to collect clinical parameters) ]
    Duration of symptoms (expressed in day)

  11. Number of classical clinical marker (qualitative variable) to diagnosis of septic arthritis [ Time Frame: Up to 1 day (time to collect clinical parameters) ]
    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)

  12. 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 joints affected (Ordinal variable)

  13. Parameters that may influence the bacteriological results of synovial fluid [ Time Frame: Up to 1 day (time to collect clinical parameters) ]
    NSAIDs, corticosteroids, antibiotics within 15 days of joint puncture (qualitative variable: Yes or No)

  14. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients performing joint puncture in routine care as part of a diagnostic assessment of acute arthritis
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age below 18 years;
  • Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819855


Contacts
Layout table for location contacts
Contact: Guillaume Coiffier 2 99 26 71 40 ext 33 guillaume.coiffier@chu-rennes.fr
Contact: Olivia Berthoud 2 99 26 71 40 ext 33 olivia.berthoud@chu-rennes.fr

Locations
Layout table for location information
France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Guillaume Coiffier    2 99 26 71 40 ext 33    guillaume.coiffier@chu-rennes.fr   
Contact: Olivia Berthoud    2 99 26 71 40 ext 33    olivia.berthoud@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Guillaume Coiffier Rennes University Hospital

Layout table for additonal information
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03819855     History of Changes
Other Study ID Numbers: 35RC18_30015_SYNOLACTATES-PLUS
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Infection