Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion (PRASEPT)
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|ClinicalTrials.gov Identifier: NCT03979937|
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment|
|Joint Effusion Septic Arthritis Arthritis||Procedure: Arthrocentesis|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||333 participants|
|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|
- Procedure: Arthrocentesis
Arthrocentesis to determine the nature of the effusion (septic or aseptic).
- 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.
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
|Contact: Christelle Jadeau, PD||0 (33) 2 43 43 43 43 ext 37 firstname.lastname@example.org|
|Centre Hospitalier Le Mans||Recruiting|
|Le Mans, France, 72 000|
|Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 email@example.com|
|Contact: Jean-Christophe Callahan, MD 0 (33) 2 43 43 43 43 ext 37 520 firstname.lastname@example.org|
|Principal Investigator: Emmanuelle DERNIS|
|Principal Investigator:||Emmanuelle Dernis, MD||Centre Hospitalier du Mans, Rheumatology Department|