Septic ArthritisDIANENCT03827759
Differentiate Children Septic and Inflammatory Arthritis by Comparative Analysis
An observational study of Septic Arthritis and Inflammatory Arthritis, run by University Hospital, Montpellier at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Arthritis, Inflammatory Arthritis, Children
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 4 Feb 2019to 29 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects of more than 6 months and under age 15 years, presenting acute arthritis, and control subjects
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hospices Civils de Lyon - pediatric rheumatology
Lyon, 69002
Hôpital Saint Joseph
Marseille, 13285
CHU Montpellier - Pediatric emergencies
Montpellier, Hérault, 34295
CHU Nîmes - Pediatrics
Nîmes, 30029
CHU Toulouse - Pediatric infectious diseases
Toulouse, 31300
About this study
Official title: 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 .
Read the 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.
- Conditions
- Septic Arthritis, Inflammatory Arthritis, Children
- Keywords
- idiopathic juvenile arthritis, septic arthritis, biomarkers
- Medical subject headings
- Arthritis, Infectious, Arthritis, Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis
Identify blood sampling proteic markers of Arthritis childhood
Measured: 1 day
Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis
Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood
Measured: 1 day
Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis
Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood
Measured: 1 day
Secondary outcomes (1)
Qualitative analysis of inflammatory process markers
Identify articular liquid sampling biomarkers (lymphocytes and interleukins) of Arthritis childhood
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start4 Feb 2019
- Primary completion6 Jun 2021
- Study completion29 Jul 2022
Why it stopped: End of the inclusion period and difficulty in recruiting the youngest patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827759
- Sponsor's protocol ID
- RECHMPL18_0293
- Other IDs
- 7683
- Acronym
- DIANE
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2019
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32849606
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis
- ClinicalTrials.gov ID
- NCT03827759
- Acronym / sponsor ID
- DIANE / RECHMPL18_0293
- Conditions
- Septic Arthritis, Inflammatory Arthritis, Children
- Keywords
- idiopathic juvenile arthritis, septic arthritis, biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: End of the inclusion period and difficulty in recruiting the youngest patients
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects of more than 6 months and under age 15 years, presenting acute arthritis, and control subjects
Key inclusion criteria (10 listed)
- 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,
- Subject of more than 6 months and under age 15 include,
Key exclusion criteria (8 listed)
- 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.
- Patient achieves of an inflammatory chronic pathology
- Patient having presented an infectious episode in the previous 8 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Qualitative analysis of inflammatory process markers
Time frame: 1 day
Results and safety
The study was stopped early (reason given: End of the inclusion period and difficulty in recruiting the youngest patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 32849606Cren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric JEZIORSKI, MD PhD study director
University Hospital, Montpellier
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Arthritis and Inflammatory Arthritis, run by University Hospital, Montpellier at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: End of the inclusion period and difficulty in recruiting the youngest patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.