NCT02505828

Brief Summary

The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

June 22, 2015

Last Update Submit

December 29, 2020

Conditions

Septic ArthritisJuvenile Idiopathic Arthritis

Keywords

ArthritissepticJuvenile idiopathic arthritisdiagnosisproteomiccytokinemonocytes

Outcome Measures

Primary Outcomes (1)

  • Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.

    Identify blood sampling biomarkers of Arthritis childhood

    1 day

Study Arms (2)

Septic arthritis

OTHER

with bacteriological identification

Procedure: Articular punction, salivary samples, blood sample

Juvenile idiopathic arthritis

OTHER

beyond the ILAR (International League of Associations for Rheumatology) definition

Procedure: Articular punction, salivary samples, blood sample

Interventions

Articular punction, salivary samples, blood samplePROCEDURE
Also known as: Proteomic analysis, Cytokine dosage, Monocyte
Juvenile idiopathic arthritisSeptic arthritis

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Septic arthritis with bacteriological identification
  • Juvenile idiopathic arthritis beyond the ILAR definition
  • Having acute arthritis requiring an articular draining
  • Child benefiting from a national insurance scheme
  • Collection of the consent of the parents or the legal representative

You may not qualify if:

  • Contraindication in an articular draining: platelet 50 000 / mm3, Rate of prothrombins lower than 70 %, activated partial thromboplastin times (APTT)\> 1,5
  • Treatment by biotherapy, corticoids or other immuno suppressor in the month preceding the articular draining.
  • Treatment by antibiotic begun more than 24 hours before the draining.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Publications (2)

  • Nziza N, Jeziorski E, Delpont M, Cren M, Chevassus H, Carbasse A, Mahe P, Abassi H, Joly-Monrigal P, Schordan E, Mange A, Jorgensen C, Apparailly F, Duroux-Richard I. Synovial-Fluid miRNA Signature for Diagnosis of Juvenile Idiopathic Arthritis. Cells. 2019 Nov 26;8(12):1521. doi: 10.3390/cells8121521.

    PMID: 31779271RESULT

  • 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.

    PMID: 32849606RESULT

MeSH Terms

Conditions

Arthritis, InfectiousArthritis, JuvenileArthritisDisease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

InfectionsJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Eric EJ JEZIORSKI, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

July 22, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations

FR(1)