- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03827759
Differentiate Children Septic and Inflammatory Arthritis by Comparative Analysis (DIANE)
Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lyon, France, 69002
- Hospices Civils de Lyon - pediatric rheumatology
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Marseille, France, 13285
- Hopital Saint Joseph
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Nîmes, France, 30029
- CHU Nîmes - Pediatrics
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Toulouse, France, 31300
- CHU Toulouse - Pediatric infectious diseases
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Hérault
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Montpellier, Hérault, France, 34295
- CHU Montpellier - Pediatric emergencies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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;
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inflammatory arthritis (group B)
Patients with idiopathic juvenile arthritis
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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.
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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
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1 day
|
Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis
Time Frame: 1 day
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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
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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
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1 day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Eric JEZIORSKI, MD PhD, University Hospital, Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL18_0293
- 7683 (UH Montpellier)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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