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Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections

NCT04661345 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-12-10

No results posted yet for this study

Summary

One of the major causes of prosthetic joint failure is infection. Recently, coagulase-negative Staphylococci (CoNS) have been identified as emergent, nosocomial pathogens involved in subclinical prosthetic joint infections (PJIs). The diagnosis of PJIs mediated by CoNS is complex and demanding due to the absence of clear clinical signs derived from the host immune system response. In this scenario, the key to successful surgical treatment is the capability to differentiate between aseptic implant loosening and septic failure. Hence, the central hypothesis of this study is that proteomic analysis of the secretome of CoNS clinical isolates associated with the characterization of patient synovial fluids will reveal a panel of putative biomarkers tightly linked to PJIs. The confirmation of the presence of bacterial PJI biomarkers in synovial fluids of infected patients will pave the way for the development of a new reliable test capable of aiding in the diagnosis of subclinical PJIs.

Conditions

  • Prosthetic Joint Infection

Interventions

OTHER

Proteomic analysis of synovial fluids

Characterization of the proteome of infected/aseptic synovial fluid for the identification of molecular hallmarks strictly related to the presence of a bacterial infection mediated by coagulase-negative Staphylococci

OTHER

Proteomic analysis of the isolated coagulase-negative Staphylococci

Characterization of the secretome of coagulase-negative Staphylococci isolated from infected prosthetic implants

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Marta Bottagisio, Ph.D. · IRCCS Istituto Ortopedico Galeazzi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2023-09-14
Completion
2023-10-14

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661345 on ClinicalTrials.gov