Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis (SYNOFRESH)

To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion

Study Overview

• Status: Completed
• Conditions: Joint Effusion
• Intervention / Treatment: Device: Infrared spectroscopy

Detailed Description

Diagnosis of a joint effusion is frequently a medical emergency, especially when septic arthritis is suspected. Septic arthritis diagnosis relies on microscopic and bacteriological analysis of synovial fluid obtained by arthrocentesis. Direct microscopic examination can be made within 2 to 12 hours but it is negative in about 50 % of the cases. It is necessary to wait 72 hours to obtain the result of the culture and reasonably rule out the diagnosis of septic arthritis. A method of establishing an immediate etiological diagnosis could improve the care of patients with joint effusion that is a therapeutic emergency and justify a hospitalization and a parenteral antibiotic therapy.

• Study Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers
  • Brest, France, 29200
    • CHRU Brest
  • Clermont-Ferrand, France, 63003
    • Chu Clermont-Ferrand
  • Nantes, France, 44000
    • CHU Nantes
  • Rennes, France, 35033
    • CHU de Rennes
  • Tours, France, 37044
    • CHRU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study

Description

Inclusion Criteria:

• patients over 18 year old
• patients with an acute arthritis defined by an evolution of less than 6 weeks
• patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
• patients who received information about the protocol and have not expressed opposition to participate

Exclusion Criteria:

• patients opposing the study
• protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis of the cause of joint effusion	The final diagnosis of the cause of joint effusion is made by the clinician based on the clinical and laboratory data : septic arthritis or other causes of arthritis	Up to 7 days (time to perform Spectroscopy and collect laboratory results)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days of hospitalization	The clinician will be asked to state how a positive or a negative result of the diagnostic test under study would have affected his decision to hospitalize the patient	Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)
Total dose of antibiotics	The clinician will be asked to state how a positive or a negative result of the diagnostic test under study would have affected his decision to start antibiotic therapy	Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2019
• Primary Completion (ACTUAL): May 8, 2021
• Study Completion (ACTUAL): May 8, 2021

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Arthritis, Infectious
• Other Study ID Numbers: 35RC18_8857_SYNOFRESH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No