Clinical Trials Logo
  1. Home
  2. Juvenile Idiopathic Arthritis
  3. NCT04460144
  4. Details
NCT04460144 Clinical Trial

Rapid Diagnostic Test for Septic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— TDR-Arthrite  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04460144
Other study ID # APHP190930
Secondary ID IDRCB 2019-A0242
Status Completed
Phase
First received
Last updated
Start date May 6, 2021
Est. completion date December 6, 2022

Study information
Verified date September 2021
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 274
Est. completion date December 6, 2022
Est. primary completion date October 21, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Months to 16 Years
Eligibility Inclusion Criteria: - Patients >3 months of age <16 years of age - Hospitalized for arthritis that started less than 6 weeks ago or patients with diagnosed inflammatory arthritis whose clinical course suggests bacterial superinfection - Indication of a joint puncture for diagnostic purposes, confirmed by a senior physician after study of all available clinical and biological elements. - Holders of parental authority who have accepted the participation of their children - Patients benefiting from a social security scheme (excluding AME) Exclusion Criteria: - Contraindications to joint puncture

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Mass spectrometry
Proteomic analysis

Locations
Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mass spectrometry profile Proteomics 15 months
See also
  Status Clinical Trial Phase
Completed NCT02776735 - An Open-label, Ascending, Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Phase 2
Active, not recruiting NCT03092427 - Probiotic Treatment in Juvenile Idiopathic Arthritis (JIA) N/A
Not yet recruiting NCT05545098 - MSUS Versus Serum Survivin and Lubricin Levels in Evaluation of Disease Activity in JIA
Not yet recruiting NCT03833609 - Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis N/A
Completed NCT02524340 - Patient Centered Adaptive Treatment Strategies Using Bayesian Causal Inference
Recruiting NCT01434082 - Sleep Patterns in Children With and Without Juvenile Idiopathic Arthritis N/A
Completed NCT04671524 - The Effect of Improvement in Function on Foot Pressure, Balance and Gait in Children With Upper Extremity Affected N/A
Recruiting NCT04167488 - Assessment of Physical Activity Among Juvenile Idiopathic Arthritis Children Performed With Actigraphy N/A
Recruiting NCT04205500 - Treatment With Specific Carbohydrate Diet in Children With Juvenile Idiopathic Arthritis N/A
Terminated NCT01694264 - Study of Anti-Viral Prophylaxis for HBsAg(+) or HBcAb(+)/HBsAb(-) Patients Starting Anti-TNFα Phase 3
Completed NCT02824978 - Therapeutic Alliance is it Associated With Better Compliance Amongst Children With Juvenile Idiopathic Arthritis ?
Active, not recruiting NCT03841357 - Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA) Phase 3
Completed NCT03833271 - The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary Early Phase 1
Completed NCT01455701 - A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 1
Completed NCT05031104 - Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis N/A
Not yet recruiting NCT01436019 - Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis N/A
Recruiting NCT05609630 - Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. Phase 3
Recruiting NCT05696340 - Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers
Recruiting NCT05545839 - Transition to Adulthood Through Coaching and Empowerment in Rheumatology N/A
Completed NCT05436301 - Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)