Joint EffusionSYNOFRESHNCT04004962
Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis
An observational study of Joint Effusion, run by Rennes University Hospital at 6 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Effusion
- What is being tested?
- Infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 360 participants
- Where
- 6 sitesFrance
- Study dates
- 16 Sep 2019to 8 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
Who may be able to join
- 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
Who cannot join
- patients opposing the study
- protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers, 49933
CHRU Brest
Brest, 29200
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
CHU Nantes
Nantes, 44000
CHU de Rennes
Rennes, 35033
CHRU Tours
Tours, 37044
About this study
To study the diagnostic performance of infrared spectroscopy on fresh synovial fluids in early septic arthritis diagnosis in patients with acute joint effusion
Read the 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.
- Conditions
- Joint Effusion
- Being tested
- Infrared spectroscopy
- Medical subject headings
- Hydrarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared spectroscopyDevice
Infrared spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 7 days (time to perform Spectroscopy and collect laboratory results)
Secondary outcomes (2)
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
Measured: 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
Measured: Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start16 Sep 2019
- Primary completion8 May 2021
- Study completion8 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint EffusionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004962
- Sponsor's protocol ID
- 35RC18_8857_SYNOFRESH
- Acronym
- SYNOFRESH
- Status last verified
- Mar 2021
- First submitted
- 25 Jun 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Infrared Spectroscopy in Fast Septic Arthritis Diagnosis
- ClinicalTrials.gov ID
- NCT04004962
- Acronym / sponsor ID
- SYNOFRESH / 35RC18_8857_SYNOFRESH
- Conditions
- Joint Effusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 8 May 2021 (actual)
- Study completion
- 8 May 2021 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients benefiting from joint fluid puncture for diagnostic purposes in the rheumatology hospitals participating in the study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients opposing the study
- protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared spectroscopyInfrared spectroscopy | Device | – |
Primary outcome
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
2 secondary outcomes
Number of days of hospitalization
Time frame: Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)
Total dose of antibiotics
Time frame: Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Effusion, run by Rennes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of the cause of joint effusion (time frame: Up to 7 days (time to perform Spectroscopy and collect laboratory results)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.