Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

Completed

• Conditions: Joint Effusion

• Registration Number: NCT04004962
• Lead Sponsor: Rennes University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-06-25
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-09-16
• Status Verified: 2021-03
• Primary Completion: 2021-05-08
• Study Completion: 2021-05-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis of the cause of joint effusion	Up to 7 days (time to perform Spectroscopy and collect laboratory results)	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

Secondary Outcome Measures

Name	Time	Method
Number of days of hospitalization	Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)	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
Total dose of antibiotics	Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)	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

Trial Locations

Locations (6)

CHRU Tours; 🇫🇷 Tours, France

CHRU Brest; 🇫🇷 Brest, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU Angers; 🇫🇷 Angers, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France