NCT01193803

Brief Summary

Osteoarticular infections are painful and disabling diseases that require antimicrobial treatment adapted to the microorganisms implicated. Microbiological cultures are currently regarded as the reference for identification of pathogenic bacteria. However, the sensitivity of these cultures is very variable and depends both on the context in which clinical samples are taken, and on the pathogen involved. The rate of detection varies according to infection type: from 50 to 70% for infectious spondylodiscitis, 65 to 95% for prosthetic joint infections, 50% for gonococcal arthritis and 90% for non-gonococcal arthritis. The aim of the study is to evaluate the diagnostic performances of microbiological cultures and molecular methods in case of osteoarticular infections. The gold standard will be established by an expert group of osteoarticular infection (composed by a bacteriologist, a radiologist, a surgeon, an anatomy-pathologist and a rheumatologist), which established the final diagnosis of infected or not infected patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 2, 2014

Status Verified

May 1, 2014

Enrollment Period

3.2 years

First QC Date

April 1, 2010

Last Update Submit

May 30, 2014

Conditions

Osteoarticular Infections

Keywords

Prosthetic Joint InfectionsVertebral OsteomyelitisSeptic arthritisMolecular methods

Outcome Measures

Primary Outcomes (1)

  • Prosthetic Joint Infections, Vertebral Osteomyelitis and Septic arthritis: Frequency of detection with classical bacteriological methods and molecular methods

    Day 0

Secondary Outcomes (1)

  • Time of returned results by one or the other of the techniques

    up to 90 days

Study Arms (6)

Spondylodiscitis control group

Patients needing vertebral biopsy looking for tumoral etiology

Procedure: Microbiological cultures and Molecular biology

Prosthetic Joint Infection control group

Patients with primary prosthetic arthrosis surgery

Procedure: Microbiological cultures and Molecular biology

Septic arthritis control group

Arthrosic patients needing evacuating articular punction with leucocytes infiltration less than 1000 /mm3

Procedure: Microbiological cultures and Molecular biology

Spondylodiscitis case group

Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context.

Procedure: Microbiological cultures and Molecular biology

Prosthetic Joint Infection case group

Patients suspected of Prosthetic Joint Infection defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context.

Procedure: Microbiological cultures and Molecular biology

Septic arthritis case group

Patients suspected of Septic arthritis without prosthesis were defined by the need of synovial punction and/or biopsy

Procedure: Microbiological cultures and Molecular biology

Interventions

Microbiological cultures and Molecular biologyPROCEDURE

Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria. Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol.

Prosthetic Joint Infection case groupProsthetic Joint Infection control groupSeptic arthritis case groupSeptic arthritis control groupSpondylodiscitis case groupSpondylodiscitis control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected diagnosis of osteoarticular infections included discitis, septic arthritis and prosthetic joint infection and control patients.

You may qualify if:

  • Patient are more than 18 years old
  • Patient who do not declined to have his medical records reviewed for research
  • Spondylodiscitis (S) group:
  • Patients suspected of Discitis and/or Vertebral Osteomyelitis is defined by the need of spinal biopsy in infectious context. Spinal biopsies will be justified by one or more clinical or imaging findings:
  • Clinical presentation
  • Spinal pain unrelieved by rest
  • Localized tenderness, Neurological deficits or limited range of motion
  • Fever \> 38°C
  • Imaging findings (plain radiographs, MRI or CT):
  • Erosions of end plates on adjacent vertebral bodies
  • Decreased height of the intervertebral disk
  • Presence of a nonvascularized zone suggesting presence of pus or necroses in intervertebral, epidural space or in paraspinal soft-tissues
  • Prosthetic Joint Infection (PJI) Group
  • Patients suspected of Prosthetic Joint Infection were defined by the need of surgical revision for diagnostic or therapeutic aiming in infectious context. This revision will be justified by one or more clinical, biological or imaging findings:
  • Clinical presentation
  • +24 more criteria

You may not qualify if:

  • Patients already include.
  • Patient without health insurance
  • Patient with one or more criteria:
  • Suspicion of concomitant infection defined by a fever \>38°C and CRP \> 10mg/l
  • Rapidly progressive arthrosis Prosthesis loosening or bone necrosis presumed to be aseptic
  • Patients with prior spinal instrumentation or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital LARIBOISIERE

Paris, 75010, France

Location

Related Publications (1)

  • Fihman V, Hannouche D, Bousson V, Bardin T, Liote F, Raskine L, Riahi J, Sanson-Le Pors MJ, Bercot B. Improved diagnosis specificity in bone and joint infections using molecular techniques. J Infect. 2007 Dec;55(6):510-7. doi: 10.1016/j.jinf.2007.09.001. Epub 2007 Oct 29.

    PMID: 18029022BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Detection of bacteria will be performed on sample provided from the osteoarticular infections like articular fluids, synovial biopsies, bone biopsies, intervertebral disc, paravertebral or epidural abscess, articular capsul...

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

InfectionsArthritisJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Beatrice BERCOT, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2010

First Posted

September 2, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

June 2, 2014

Record last verified: 2014-05

Locations

FR(1)