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TDR-Arthrite: Rapid Diagnostic Test for Septic Arthritis

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04460144
Collaborator
(none)
60
Enrollment
1
Location
19
Anticipated Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Mass spectrometry

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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.
Actual Study Start Date :
May 6, 2021
Anticipated Primary Completion Date :
May 6, 2022
Anticipated Study Completion Date :
Dec 6, 2022

Outcome Measures

Primary Outcome Measures

  1. Mass spectrometry profile [15 months]

    Proteomics

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Debre Hospital Paris France 75019

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Ulrich MEINZER, MD-PhD, APHP
  • Study Director: Stephane BONACORSI, MD-PhD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04460144
Other Study ID Numbers:
  • APHP190930
  • IDRCB 2019-A02427-50
First Posted:
Jul 7, 2020
Last Update Posted:
Oct 4, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis, Infectious
Arthritis
Arthritis, Juvenile

Study Results

No Results Posted as of Oct 4, 2021