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Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion (PRASEPT)

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: NCT03979937
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier le Mans

Brief Summary:
Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.

Condition or disease Intervention/treatment
Joint Effusion Septic Arthritis Arthritis Procedure: Arthrocentesis

Detailed Description:

In accordance with guidelines and because of the potential gravity that this situation could represent, any joint effusion must be considered as a septic arthritis until proven otherwise, thus justifying an arthrocentesis and an adequate treatment. Nevertheless, because of epidemiology in primary care, this pragmatic attitude is quite commonly obscured and practices vary according to the experience of the doctor and his personal habits. As a result, the arthrocentesis is not commonly performed and anti-inflammatory treatment, whether based on NSAIDs or corticosteroids, is even sometimes administered to the patient despite the contrary guidelines. Although usually effective, this attitude is however not without risks. In this context, it seems interesting to develop a simple, reproducible and applicable diagnostic tool in a primary care setting for predicting the risk of septic arthritis.

This study is therefore aimed at the development and validation of a predictive score based on simple clinical and paraclinical data (such as the macroscopic appearance of the synovial fluid removed) in a patient with an effusion, whatever either the clinical presentation, whether isolated or integrated in a more complex clinical presentation, whether associated with locoregional inflammatory or general signs or not.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 333 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion
Actual Study Start Date : February 13, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Arthrocentesis
    Arthrocentesis to determine the nature of the effusion (septic or aseptic).


Primary Outcome Measures :
  1. Presence of a septic arthritis [ Time Frame: 10 days after the arthrocentesis. ]
    Presence of more than 2000 cells/mL and bacterial growth in the articular fluid.



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
Sampling Method:   Non-Probability Sample
Study Population
All adult patients presenting with at least one clinical joint effusion accessible to arthrocentesis, interesting a native non operated joint, without any general antibiotic therapy in the previous 15 days.
Criteria

Inclusion Criteria:

  • Adult patient (age ≥ 18 years)
  • Hospitalized in the conventional hospitalization unit or day hospitalization unit or received in consultation within the Rheumatology or Infectious Diseases units at the Le Mans General Hospital
  • presenting at least one joint effusion at clinical examination
  • Interesting a native, nonoperated joint, accessible to a puncture based on clinical markers, determined by palpatory anatomy
  • Affiliated to social security
  • No opposition expressed after written information

Exclusion Criteria:

  • General antibiotic therapy in progress or completed less than 15 days before
  • Failure to perform the arthrocentesis
  • Person subject to a legal protection measure, not allowing his compliance with the study
  • Participant already included in another study (exclusivity clause)

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): NCT03979937


Contacts
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Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 cjadeau@ch-lemans.fr

Locations
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France
Centre Hospitalier Le Mans Recruiting
Le Mans, France, 72 000
Contact: Christelle Jadeau, PD    0 (33) 2 43 43 43 43 ext 37 482    cjadeau@ch-lemans.fr   
Contact: Jean-Christophe Callahan, MD    0 (33) 2 43 43 43 43 ext 37 520    jccallahan@ch-lemans.fr   
Principal Investigator: Emmanuelle DERNIS         
Sponsors and Collaborators
Centre Hospitalier le Mans
Investigators
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Principal Investigator: Emmanuelle Dernis, MD Centre Hospitalier du Mans, Rheumatology Department

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Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03979937    
Other Study ID Numbers: CHM-2019/S7/03
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: June 2019
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
Hydrarthrosis
Joint Diseases
Musculoskeletal Diseases
Infection