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

November 18, 2022 updated by: University Hospital, Montpellier

Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis

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 .

Study Overview

Status

Active, not recruiting

Detailed Description

This a multicentric prospective study that compares biological fluids as synovial liquid and blood samples to find biomarkers that could distinguish septic arthritis and juvenile idiopathic arthritis. Prospectively, patients will be recruited under the age of 15 who are in care for septic or inflammatory arthritis at the University Hospitals of Montpellier, Lyon, Nimes and Toulouse. Patients should have an indication of blood and synovial as part of their management :

Group A: 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.

Group B: Idiopathic juvenile arthritis and control topics (Group C). In this project, the aim is to analyze all in all 50 articular liquids and serum of inflammatory arthritises (Group B), and 30 articular liquids and serum of infectious confirmed arthritises (Group A) which will require the inclusion about 50 possibly septic arthritis. The diagnosis of infectious arthritis is not immediate, he(it) is confirmed at the latest three weeks after the draining. So a group of control will be constituted.

Group C: the blood of 20 healthy children matched by the age and at the sex in the groups A and B will be collected to analyze elements studied in the blood.

  • 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

    • Non inclusion 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

Methods of measure of assessment criteria

Analysis will be done on blood samples and synovial liquid, that remains after sample collected for the management of their disease. The blood test and an synovial liquid draining will be realized at the subject. Before freezing, aliquots will be realized so that every analysis can benefit from a minimum volume:

  • Cellular analyses: will be only made in Montpellier and established by the set of collected cells (no necessary volume).
  • Proteomic, MiRNA analysis and cytokine dosing will been done in the second time.

Statistical analysis will be done to individualize biomarkers.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lyon, France, 69002
        • Hospices Civils de Lyon - pediatric rheumatology
      • Marseille, France, 13285
        • Hopital Saint Joseph
      • Nîmes, France, 30029
        • CHU Nîmes - Pediatrics
      • Toulouse, France, 31300
        • CHU Toulouse - Pediatric infectious diseases
    • Hérault
      • Montpellier, Hérault, France, 34295
        • CHU Montpellier - Pediatric emergencies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day
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
1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis of inflammatory process markers
Time Frame: 1 day
Identify articular liquid sampling biomarkers (lymphocytes and interleukins) of Arthritis childhood
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Eric JEZIORSKI, MD PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

July 25, 2022

Study Completion (Anticipated)

August 4, 2024

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • RECHMPL18_0293
  • 7683 (UH Montpellier)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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