NCT04460144

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

May 6, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

January 4, 2023

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

July 1, 2020

Last Update Submit

January 3, 2023

Conditions

Juvenile Idiopathic ArthritisArthritis, SepticArthritis, Unspecified

Outcome Measures

Primary Outcomes (1)

  • Mass spectrometry profile

    Proteomics

    15 months

Interventions

Mass spectrometryDIAGNOSTIC_TEST

Proteomic analysis

Eligibility Criteria

Age3 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute arthritis

You may qualify if:

  • 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)

You may not qualify if:

  • Contraindications to joint puncture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

synovial fluid blood sample stool sample nasal swab

MeSH Terms

Conditions

Arthritis, JuvenileArthritis, InfectiousArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesInfections

Study Officials

  • Ulrich MEINZER, MD-PhD

    APHP

    PRINCIPAL INVESTIGATOR

  • Stephane BONACORSI, MD-PhD

    APHP

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

May 6, 2021

Primary Completion

October 21, 2022

Study Completion

December 6, 2022

Last Updated

January 4, 2023

Record last verified: 2021-09

Locations

FR(1)