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

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: NCT04004962
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Joint Effusion 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.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Infrared spectroscopy
    Infrared spectroscopy


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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

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

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): NCT04004962


Contacts
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Contact: Jean-David Albert, MD 02.99.26.71.40 jean-david.albert@chu-rennes.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Emmanuel HOPPE, MD    02.41.35.38.34    EmHoppe@chu-angers.fr   
CHRU Brest Recruiting
Brest, France, 29200
Contact: Thierry MARHADOUR, MD    02.98.22.33.33    thierry.marhadour@chu-brest.fr   
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Marion COUDERC, MD    04.73.75.14.88    mcouderc@chu-clermontferrand.fr   
CHU Nantes Recruiting
Nantes, France, 44000
Contact: Benoit LE GOFF, MD, PhD    02.40.08.33.33    benoit.legoff@chu-nantes.fr   
CHU de Rennes Recruiting
Rennes, France, 35033
Contact: Jean-David Albert, MD    02.99.26.71.40    jean-david.albert@chu-rennes.fr   
CHRU Tours Recruiting
Tours, France, 37044
Contact: Philippe GOUPILLE, MD, PhD    02.18.37.05.89    philippe.goupille@univ-tours.fr   
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04004962    
Other Study ID Numbers: 35RC18_8857_SYNOFRESH
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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