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Completed

NCT Number: NCT04004962

Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis

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

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Key information

Conditions

Joint Effusion Hydrarthrosis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infrared spectroscopy

Device

Infrared spectroscopy

Primary outcomes

  1. Diagnosis of the cause of joint effusion

    Time frame: 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 outcomes

  1. Number of days of hospitalization

    Time frame: 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

  2. Total dose of antibiotics

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: SYNOFRESH

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2019
Registry last updated
Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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