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

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ClinicalTrials.gov Identifier: NCT03827759

Recruitment Status : Active, not recruiting

First Posted : February 1, 2019

Last Update Posted : November 21, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

INSERM U1183

Information provided by (Responsible Party):

University Hospital, Montpellier

Study Description

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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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 Design

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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

MedlinePlus related topics: Arthritis Infectious Arthritis

Genetic and Rare Diseases Information Center resources: Infectious Arthritis

U.S. FDA Resources

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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
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
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 :

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.

Eligibility Criteria

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

Contacts and Locations

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

More Information

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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

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