Determination of New Biomarkers of Septic Arthritis by Su... | NCT01010165

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

NCT01010165

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Oct 26, 2012Estimated

Enrollment

89Actual

Phase

Not provided

Conditions

Acute Arthritis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00810-57	Registry Identifier	RCB

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Nov 6, 2009

First Submission Date that Met QC Criteria

Nov 6, 2009

First Posted Date

Nov 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2012

Last Update Posted Date

Oct 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

89Actual

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients from the Grenoble University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
olivier epaulard, MD, PhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Grenoble		38000	France

Condition Browse Module

MeSH Terms

ID	Term
D000070657	Crystal Arthropathies

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided