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Completed

NCT Number: NCT04460144

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mass spectrometry

Diagnostic Test

Proteomic analysis

Primary outcomes

  1. Mass spectrometry profile

    Time frame: 15 months

    Proteomics

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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.

Acronym: TDR-Arthrite

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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