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

NCT04661345 | Unknown

• 1 other identifier: SINOVIOMA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthopedics; Proteomics; Synovial Fluids Biomarkers; Coagulase-negative Staphylococci

Outcome Measures

Primary Outcomes (1)

• Identification of molecular hallmarks strictly related to the presence of coagulase-negative Staphylococci in synovial fluids

  Characterization of the synovial fluids of septic/aseptic enrolled patients for the identification of a pool of protein of interest strictly related to the presence of coaglase-negative Staphylococci

  3 years

Secondary Outcomes (1)

• Proteomic analysis of coagulase-negative Staphylococci

  3 years

Study Arms (2)

Septic group

The septic group is composed of patients with prosthetic joint infection mediated by coagulase-negative Staphylococci (CoNS)

Other: Proteomic analysis of synovial fluids; Other: Proteomic analysis of the isolated coagulase-negative Staphylococci

Aseptic group

The aseptic group is composed of patients with implant failure unrelated to infection.

Other: Proteomic analysis of synovial fluids

Interventions

Proteomic analysis of synovial fluids OTHER

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

Aseptic group; Septic group

Proteomic analysis of the isolated coagulase-negative Staphylococci OTHER

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

Septic group

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 subjected to a revision of the articular prosthesis due to bacterial infection or to an aseptic loosening of the implant

You may qualify if:

• ≥ 18 years old patients
• Patients subjected to a revision of the articular prosthesis due to bacterial infection mediated by coagulase-negative Staphylococci (CoNS) or to an aseptic failure of the implant
• Collection of a sufficient volume of synovial fluid
• Patient consent by signing an informed consent form

You may not qualify if:

• Collection of a hemolytic sample

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

bacterial strain

Study Officials

• Marta Bottagisio, Ph.D.

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera, MSc

CONTACT

00390266214057; elena.cittera@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 3, 2020
• First Posted: December 10, 2020
• Study Start: October 14, 2020
• Primary Completion: September 14, 2023
• Study Completion: October 14, 2023
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

IT (1)