NCT03827759

Brief Summary

The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

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

January 23, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2022

Completed
Last Updated

April 24, 2026

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

January 23, 2019

Last Update Submit

April 21, 2026

Conditions

Keywords

idiopathic juvenile arthritis, septic arthritis, biomarkers

Outcome Measures

Primary Outcomes (3)

  • Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis

    Identify blood sampling proteic markers of Arthritis childhood

    1 day

  • Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis

    Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood

    1 day

  • Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis

    Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood

    1 day

Secondary Outcomes (1)

  • Qualitative analysis of inflammatory process markers

    1 day

Study Arms (3)

septic arthritis (group A)

Patients with acute juvenile arthritis with suspicion of bacterial infection,confirmed on a bacteriological plan, either by culture of the articular liquid or by blood culture, or by molecular biology in the articular liquid;

inflammatory arthritis (group B)

Patients with idiopathic juvenile arthritis

control (group C)

Healthy children who are matched by the age and at the sex in the groups A and B, to analyze elements studied in the blood.

Eligibility Criteria

Age6 Months - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Subjects of more than 6 months and under age 15 years, presenting acute arthritis, and control subjects

You may qualify if:

  • Group A and group B:
  • Subject of more than 6 months and under age 15 years,
  • Presenting acute arthritis taken care in the University Hospitals of Montpellier, Nimes, Toulouse or Lyon, and requiring an articular puncture,
  • Child benefiting from a social security system,
  • Collection of the consent of the legal parents/representatives,
  • Group C:
  • Subject of more than 6 months and under age 15 include,
  • Taken care in the University Hospital of Montpellier, and requiring a venous draining,
  • Child benefiting from a social security system,
  • Collection of the consent of the legal parents/representatives

You may not qualify if:

  • Group A and group B:
  • Contraindication in an articular draining: platelet 50 000/mm3, pathologic hemostasis
  • Treatment by biological therapy, corticoids or other immunosuppressant treatment in the month preceding the articular draining,
  • Group C:
  • Patient achieves of an inflammatory chronic pathology
  • Patient having presented an infectious episode in the previous 8 days
  • Patients under immunosuppressor or anti-infective

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Montpellier - Pediatric emergencies

Montpellier, Hérault, 34295, France

Location

Hospices Civils de Lyon - pediatric rheumatology

Lyon, 69002, France

Location

Hôpital Saint Joseph

Marseille, 13285, France

Location

CHU Nîmes - Pediatrics

Nîmes, 30029, France

Location

CHU Toulouse - Pediatric infectious diseases

Toulouse, 31300, France

Location

Related Publications (1)

  • Cren M, Nziza N, Carbasse A, Mahe P, Dufourcq-Lopez E, Delpont M, Chevassus H, Khalil M, Mura T, Duroux-Richard I, Apparailly F, Jeziorski E, Louis-Plence P. Differential Accumulation and Activation of Monocyte and Dendritic Cell Subsets in Inflamed Synovial Fluid Discriminates Between Juvenile Idiopathic Arthritis and Septic Arthritis. Front Immunol. 2020 Jul 31;11:1716. doi: 10.3389/fimmu.2020.01716. eCollection 2020.

Biospecimen

Retention: SAMPLES WITH DNA

Synovial liquid and blood samples (with : proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping) will be analysed.

MeSH Terms

Conditions

Arthritis, InfectiousArthritisArthritis, Juvenile

Condition Hierarchy (Ancestors)

InfectionsJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric JEZIORSKI, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 23, 2019

First Posted

February 1, 2019

Study Start

February 4, 2019

Primary Completion

June 6, 2021

Study Completion

July 29, 2022

Last Updated

April 24, 2026

Record last verified: 2025-06

Locations