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Differentiate Children Septic and Inflammatory Arthritis by Comparative Analysis (DIANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827759
Recruitment Status : Active, not recruiting
First Posted : February 1, 2019
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
INSERM U1183
Information provided by (Responsible Party):
University Hospital, Montpellier

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 .

Condition or disease
Septic Arthritis Inflammatory Arthritis Children

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis
Actual Study Start Date : February 4, 2019
Actual Primary Completion Date : July 25, 2022
Estimated Study Completion Date : August 4, 2024

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis [ Time Frame: 1 day ]
    Identify blood sampling proteic markers of Arthritis childhood

  2. Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis [ Time Frame: 1 day ]
    Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood

  3. Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis [ Time Frame: 1 day ]
    Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood


Secondary Outcome Measures :
  1. Qualitative analysis of inflammatory process markers [ Time Frame: 1 day ]
    Identify articular liquid sampling biomarkers (lymphocytes and interleukins) of Arthritis childhood


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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects of more than 6 months and under age 15 years, presenting acute arthritis, and control subjects
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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,
  • antibiotic begun more than 24 hours before the inclusion.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827759


Locations
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France
CHU Montpellier - Pediatric emergencies
Montpellier, Hérault, France, 34295
Hospices Civils de Lyon - pediatric rheumatology
Lyon, France, 69002
Hôpital Saint Joseph
Marseille, France, 13285
CHU Nîmes - Pediatrics
Nîmes, France, 30029
CHU Toulouse - Pediatric infectious diseases
Toulouse, France, 31300
Sponsors and Collaborators
University Hospital, Montpellier
INSERM U1183
Investigators
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Study Director: Eric JEZIORSKI, MD PhD University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03827759    
Other Study ID Numbers: RECHMPL18_0293
7683 ( Other Identifier: UH Montpellier )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
idiopathic juvenile arthritis, septic arthritis, biomarkers
Additional relevant MeSH terms:
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Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Infections