Rapid Diagnostic Test for Septic Arthritis

NCT ID: NCT04460144

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-06

Study Completion Date

2022-12-06

Brief Summary

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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

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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

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Juvenile Idiopathic Arthritis Arthritis, Septic Arthritis, Unspecified

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mass spectrometry

Proteomic analysis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulrich MEINZER, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

APHP

Stephane BONACORSI, MD-PhD

Role: STUDY_DIRECTOR

APHP

Locations

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Robert Debre Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB 2019-A02427-50

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190930

Identifier Type: -

Identifier Source: org_study_id

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