Trials / Completed
CompletedNCT04460144
Rapid Diagnostic Test for Septic Arthritis
Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 274 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 3 Months – 16 Years
- Healthy volunteers
- Not accepted
Summary
Diagnostic Validation Study of a Test Based on the Analysis of the Proteome by Mass Spectrometry for the Diagnosis of Septic Arthritis in Children Under 16 Years of Age
Detailed description
Arthritis is an inflammation of the joints that can have many causes. In children, septic arthritis (SA) is the most common cause of acute arthritis (around 45% of cases). Juvenile Idiopathic Arthritis (JIA) is a disease characterized the presence of arthritis in one or more of unknown origin in children under 16 years of age, lasting more than 6 weeks. It is the most common pediatric rheumatological disease with a prevalence of 16 to 150 cases per 100,000 children. Finally, in approximately 40% of children the origin of acute arthritis remains undetermined (ND arthritis). In this group, all the examinations performed are not in favor of a bacterial origin and the evolution of arthritis do not allow the diagnosis of JIA to be retained and no other disease is found. During the first few days of arthritis, differentiation between AS and non-septic arthritis is difficult. The available clinical and biological parameters do not allow for easy and rapid differentiation between AS and non-septic arthritis. This project aims to develop a new diagnostic technique based on molecular analysis of the proteome in the joint puncture fluid.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Mass spectrometry | Proteomic analysis |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2022-10-21
- Completion
- 2022-12-06
- First posted
- 2020-07-07
- Last updated
- 2023-01-04
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04460144. Inclusion in this directory is not an endorsement.