Determination of New Biomarkers of Septic Arthritis by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF) (NOUBASST)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01010165

First received: November 6, 2009

Last updated: October 25, 2012

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 6, 2009

Last Updated Date

October 25, 2012

Start Date ^ICMJE

October 2009

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01010165 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Determination of New Biomarkers of Septic Arthritis by Surface-Enhanced Laser Desorption/Ionization Time-Of-Flight (SELDI-TOF)

Official Title ^ICMJE

Caractérisation de Nouveaux Biomarqueurs de l'Arthrite Septique Par Technique SELDI-TOF

Brief 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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

joint fluid proteom

Sampling Method

Non-Probability Sample

Study Population

patients from the Grenoble University Hospital

Condition ^ICMJE

Acute Arthritis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

septic arthritis
crystal arthritis
rheumatismal disease

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

acute arthritis (onset not more than 7 days ago)
joint fluid leukocyte count : more than 2000/mm3, more than 50% polymorphonuclear

Exclusion Criteria:

none (apart from unability to accept inclusion)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01010165

Other Study ID Numbers ^ICMJE

0916, 2009-A00810-57

Has Data Monitoring Committee

Responsible Party

University Hospital, Grenoble

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

olivier epaulard, MD, PhD

University Hospital, Grenoble

Information Provided By

University Hospital, Grenoble

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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