Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

Joint Effusion Clinical Trial

— SYNOFRESH  

Official title:

Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04004962
• Other study ID #: 35RC18_8857_SYNOFRESH
• Status: Completed
• Start date: September 16, 2019
• Est. completion date: May 8, 2021

Study information

• Verified date: March 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: May 8, 2021
• Est. primary completion date: May 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Joint Effusion

Intervention

Device:
• Infrared spectroscopy
Infrared spectroscopy

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	CHU Clermont-Ferrand	Clermont-Ferrand
France	CHU Nantes	Nantes
France	CHU de Rennes	Rennes
France	CHRU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)