Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections
NCT ID: NCT04661345
Last Updated: 2020-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-10-14
2023-10-14
Brief Summary
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Detailed Description
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According to MSIS guidelines, the measurement of CRP and ESR levels, synovial WBC count, and the microbiological culture of the explanted device and periprosthetic tissue will be conducted following routine protocols. Only synovial fluid collected from patients of the infected group diagnosed with a PJI mediated by CoNS will be eligible for subsequent proteomic analyses. Task 1.2: The secretome of at least 10 isolates of the retrieved species of CoNS will be characterized. In particular, CoNS clinical isolates will be cultured in a drip flow reactor to induce the production of biofilm and the secretome analyzed to perform the first selection of proteins of interest.
Task 2.1: Proteins extracted from the synovial fluids of patients with or without PJI will be carbamidomethylated and digested by trypsin. Thereafter, peptide mixtures will be analyzed by nano liquid chromatography coupled to tandem mass spectrometry (nano LC-MS/MS). Label-free quantifications (LFQ) will be applied to assess the levels of proteins expressed by bacteria and secreted in patient synovial fluids.
Task 2.2: Using proteomic software (i.e. MaxQuant, Perseus, etc.), the bioinformatic analysis will be performed to determine a pool of proteins of interest present only in samples belonging to the infected group of patients which would be closely related to the presence of bacteria.
Task 3.1: Proteins of interest identified in Task 1.2 and Task 2.2 as putative biomarkers related to CoNS-mediated PJIs will be selected for targeted proteomic analyses by means of additional bioinformatic analyses.
Task 3.2: To confirm the presence of putative biomarkers defined in Task 3.1 in synovial fluid of enrolled patients, targeted proteomic analysis will be performed on all the infected/not infected samples collected in Task 1.1. Prototypic peptides for each putative biomarker will be selected by Skyline software. Ionization and fragmentation behaviors of all candidate peptides will be studied.
Task 3.3: Finally, the information from the targeted proteomic analysis will be correlated to the outcomes of the diagnosis formulated following the MSIS guidelines in order to evaluate the diagnostic value of each selected biomarker.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Septic group
The septic group is composed of patients with prosthetic joint infection mediated by coagulase-negative Staphylococci (CoNS)
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
Proteomic analysis of the isolated coagulase-negative Staphylococci
Characterization of the secretome of coagulase-negative Staphylococci isolated from infected prosthetic implants
Aseptic group
The aseptic group is composed of patients with implant failure unrelated to infection.
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
Interventions
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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
Proteomic analysis of the isolated coagulase-negative Staphylococci
Characterization of the secretome of coagulase-negative Staphylococci isolated from infected prosthetic implants
Eligibility Criteria
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Inclusion Criteria
* 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
* Collection of a hemolytic sample
18 Years
ALL
No
Sponsors
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
OTHER
Responsible Party
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Principal Investigators
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Marta Bottagisio, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
IRCCS Istituto Ortopedico Galeazzi
Locations
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IRCCS Istituto Ortopedico Galeazzi
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Elena Cittera, MSc
Role: primary
Other Identifiers
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SINOVIOMA
Identifier Type: -
Identifier Source: org_study_id