Acute ArthritisNOUBASSTNCT01010165
Determination of New Biomarkers of Septic Arthritis by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF)
An observational study of Acute Arthritis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Arthritis
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from the Grenoble University Hospital
Who may be able to join
- acute arthritis (onset not more than 7 days ago)
- joint fluid leukocyte count : more than 2000/mm3, more than 50% polymorphonuclear
Who cannot join
- none (apart from unability to accept inclusion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caractérisation de Nouveaux Biomarqueurs de l'Arthrite Septique Par Technique SELDI-TOF
Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic therapy).
This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new biomarkers of a septic origin.
Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of admission.
- Conditions
- Acute Arthritis
- Keywords
- acute arthritis, bacteria, crystal arthritis, proteomic, SELDI-TOF
- Medical subject headings
- Crystal Arthropathies
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 | Not described | |
| crystal arthritis | Not described | |
| rheumatismal disease | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- olivier epaulard, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010165
- Sponsor's protocol ID
- 0916
- Other IDs
- 2009-A00810-57
- Acronym
- NOUBASST
- Status last verified
- Dec 2011
- First submitted
- 6 Nov 2009
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caractérisation de Nouveaux Biomarqueurs de l'Arthrite Septique Par Technique SELDI-TOF
- ClinicalTrials.gov ID
- NCT01010165
- Acronym / sponsor ID
- NOUBASST / 0916
- Conditions
- Acute Arthritis
- Keywords
- acute arthritis, bacteria, crystal arthritis, proteomic, SELDI-TOF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Nov 2009 (estimated)
- 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.
Septic arthritis is a frequent, potentially disabling and/or life-threatening disease. To diagnose a septic arthritis is a complex procedure, first because of numerous differential diagnoses (such as crystal arthritis), second because of poor sensitivity of initial gram staining (for example after untimely antibiotic therapy).
This protocol will use SELDI-TOF as a tool to analyse joint fluid of patients with various acute, polymorphonuclear-rich arthritis, as to determine specific and sensitive new biomarkers of a septic origin.
Such biomarkers will allow rapid diagnosis of septic arthritis in the first hours of admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| septic arthritis | – | – |
| crystal arthritis | – | – |
| rheumatismal disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from the Grenoble University Hospital
Key inclusion criteria (2 listed)
- acute arthritis (onset not more than 7 days ago)
- joint fluid leukocyte count : more than 2000/mm3, more than 50% polymorphonuclear
Key exclusion criteria (1 listed)
- none (apart from unability to accept inclusion)
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
Related trials for Acute Arthritis
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Active, not recruiting
Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
Healthy, Hyperuricemia, Gout
Enrolling by invitation
VR for Steroid Joint Injections - Feasibility
Acute Pain, Procedural Anxiety
RecruitingObservational study
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Knee Osteoarthritis
Not yet recruitingPhase 2
A Study of Efficacy and Safety of IBI3011 in Subjects With Acute Gouty Arthritis
Acute Gouty Arthritis
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.
olivier epaulard, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Arthritis, run by University Hospital, Grenoble at 1 site 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 26 Oct 2012.