NCT04004962

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2021

Completed
Last Updated

August 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

June 25, 2019

Last Update Submit

August 10, 2021

Conditions

Joint Effusion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of days of hospitalization

    Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)

  • Total dose of antibiotics

    Up to 2 months (time to collect data on hospitalization duration and antibiotic therapy duration)

Interventions

Infrared spectroscopyDEVICE

Infrared spectroscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • patients opposing the study
  • protected major (safeguard justice, trusteeship and guardianship) and persons deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

CHU Angers

Angers, 49933, France

Location

CHRU Brest

Brest, 29200, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Nantes

Nantes, 44000, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHRU Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Hydrarthrosis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2019

First Posted

July 2, 2019

Study Start

September 16, 2019

Primary Completion

May 8, 2021

Study Completion

May 8, 2021

Last Updated

August 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)