Back to resultsARTEMIS Synovial Markers in Arthritis Childhood (ARTEMIS)
Primary Purpose
Septic Arthritis, Juvenile Idiopathic Arthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Articular punction, salivary samples, blood sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Septic Arthritis focused on measuring Arthritis, septic, Juvenile idiopathic arthritis, diagnosis, proteomic, cytokine, monocytes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Hôpital Arnaud de Villeneuve
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Septic arthritis
Juvenile idiopathic arthritis
Arm Description
with bacteriological identification
beyond the ILAR (International League of Associations for Rheumatology) definition
Outcomes
Primary Outcome Measures
Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.
Identify blood sampling biomarkers of Arthritis childhood
Secondary Outcome Measures
Full Information
NCT ID
NCT02505828
First Posted
June 22, 2015
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02505828
Brief Title
ARTEMIS Synovial Markers in Arthritis Childhood
Acronym
ARTEMIS
Official Title
ARTEMIS Synovial Markers in Arthritis Childhood
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Arthritis, Juvenile Idiopathic Arthritis
Keywords
Arthritis, septic, Juvenile idiopathic arthritis, diagnosis, proteomic, cytokine, monocytes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Septic arthritis
Arm Type
Other
Arm Description
with bacteriological identification
Arm Title
Juvenile idiopathic arthritis
Arm Type
Other
Arm Description
beyond the ILAR (International League of Associations for Rheumatology) definition
Intervention Type
Procedure
Intervention Name(s)
Articular punction, salivary samples, blood sample
Other Intervention Name(s)
Proteomic analysis, Cytokine dosage, Monocyte
Primary Outcome Measure Information:
Title
Qualitative analysis of new biological markers (proteic, cytokine or cellular) that discriminate inflammatory and infectious arthritis.
Description
Identify blood sampling biomarkers of Arthritis childhood
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric EJ JEZIORSKI, MD, PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31779271
Citation
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.
Results Reference
result
PubMed Identifier
32849606
Citation
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.
Results Reference
result
Learn more about this trial
ARTEMIS Synovial Markers in Arthritis Childhood
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