New Strategies for Biofilm Related Infections

NCT03784807 | Unknown

• 1 other identifier: Diafilm
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop new assays for synovial fluid analysis able to improve diagnosis of prosthetic joint infections. In particular, use of synovial calprotectin as marker of infection, confocal laser scanning microscopy (CLSM) analysis and methods to assess antimicrobial susceptibility will be evaluated in synovial fluids collected from patients with septic and aseptic failure of the prosthetic implant.

Conditions

Prosthetic Joint Infection

Keywords

synovial fluid analysis

Outcome Measures

Primary Outcomes (1)

• Assessment of analytical performance of calprotectin and CLSM for diagnosis of prosthetic joint infections

  Sensitivity, specificity, predictive values and diagnostic accuracy of calprotectin and CLSM will be calculated and compared to those of assays already used for diagnosis of prosthetic joint infections

  preoperative visit or during surgery

Secondary Outcomes (1)

• Improvement in antibiotic therapy applying data obtained from antibiotic susceptibility testing on biofilm

  Afetr isolation of the pathogen, within 2 months

Study Arms (2)

Infected

Patients with prosthetic joint or osteoarticular infection

Diagnostic Test: synovial calprotectin, confocal laser microscopy

Not infected

Patients with implant failure not due to infection

Diagnostic Test: synovial calprotectin, confocal laser microscopy

Interventions

synovial calprotectin, confocal laser microscopy DIAGNOSTIC_TEST

Calprotectin will be determined in synovial fluid of patients with septic and aseptic failure of their prosthesis. CLSM will be used to detect presence of microorganisms in synovial fluid. Susceptibility to antimicrobials of bacterial strains isolated from patients with prosthetic joint infections will be assessed using planktonic cells and biofilm associated bacteria

Infected; Not infected

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with osteoarticular or prosthetic joint infection

You may qualify if:

• Diagnosis of implant failure or osteoarticular infections
• Collection of a sufficient amount of synovial fluid
• Informed Consent signed

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial strains

Study Officials

• Elena De Vecchi, MSc

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera, MSc

CONTACT

00390266214057; elena.cittera@grupposandonato.it

Elena De Vecchi, MSc

CONTACT

00390266214080; elena.devecchi@grupposandonato.it

Study Design

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

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 24, 2018
• Study Start: November 2, 2018
• Primary Completion: September 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 24, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available within 1 year from study conclusion
• Access Criteria: Requests should be sent by e-mail to the Institution

Locations

IT (1)