- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661345
Identification of Molecular Marker of Coagulase-negative Staphylococci for the Diagnosis of Prosthetic Joint Infections
Molecular Hallmarks of Coagulase-negative Staphylococci: Toward the Identification of Biomarkers for the Rapid Diagnosis of Subclinical Periprosthetic Joint Infections
Study Overview
Status
Conditions
Detailed Description
Task 1.1: Synovial fluids will be collected from 60 patients referred to IRCCS Galeazzi Orthopedic Institute for the revision of a septic prosthesis and from 40 patients undergoing revision due to aseptic failure. The collected synovial fluids will be stored at -80°C until analysis.
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Elena Cittera, MSc
- Phone Number: 00390266214057
- Email: elena.cittera@grupposandonato.it
Study Locations
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Milan, Italy, 20161
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
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Contact:
- Elena Cittera, MSc
- Phone Number: 00390266214057
- Email: elena.cittera@grupposandonato.it
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Sub-Investigator:
- Marta Bottagisio, Ph.D.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- Patients not fulfilling the inclusion criteria
- Collection of a hemolytic sample
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Septic group
The septic group is composed of patients with prosthetic joint infection mediated by coagulase-negative Staphylococci (CoNS)
|
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
Characterization of the secretome of coagulase-negative Staphylococci isolated from infected prosthetic implants
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Aseptic group
The aseptic group is composed of patients with implant failure unrelated to infection.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of molecular hallmarks strictly related to the presence of coagulase-negative Staphylococci in synovial fluids
Time Frame: 3 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proteomic analysis of coagulase-negative Staphylococci
Time Frame: 3 years
|
Characterization of the secretome of CoNS clinical isolate, and the characterization of the proteome of the synovial fluids of septic/aseptic enrolled patients
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3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marta Bottagisio, Ph.D., IRCCS Istituto Ortopedico Galeazzi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SINOVIOMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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