- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07796555
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus Isolates From Surgical Site Infections Exposed to Probiotic Cell-Free Supernatant
Study Overview
Status
Detailed Description
The global emergence and dissemination of methicillin-resistant Staphylococcus aureus (MRSA) have further complicated the treatment of these infections because of its resistance to β-lactam antibiotics and many other antimicrobial agents, leading to increased morbidity, mortality, prolonged hospitalization, and substantial healthcare costs worldwide.
The pathogenicity of Staphylococcus aureus is largely attributed to its diverse virulence factors, which facilitate bacterial adhesion, tissue invasion, immune evasion, and persistence within the host. These virulence determinants include microbial surface components recognizing adhesive matrix molecule, extracellular enzymes, cytotoxins, superantigens, and immune evasion proteins, all of which contribute to successful colonization and disease progression .
Among these virulence factors, biofilm formation is considered one of the most important determinants of S. aureus pathogenicity. Biofilms are highly organized bacterial communities embedded within a self-produced extracellular polymeric matrix (EPS). This matrix enhances bacterial adherence to both biotic and abiotic surfaces while protecting the bacteria from host immune defenses and antimicrobial agents .
Consequently, biofilm-associated infections are often characterized by persistent infection, failure in treatment , and increased antimicrobial resistance, Therefore, disrupting biofilm formation has become a key target for developing novel therapeutic strategies.
Probiotics have attracted increasing attention as promising addition to conventional antimicrobial therapy because of their ability to inhibit pathogenic microorganisms, interfere with biofilm formation, and modulate bacterial virulence .
Many of these beneficial effects are mediated by probiotic-derived cell-free supernatants (CFS), which contain a variety of bioactive compounds, including organic acids, bacteriocins, hydrogen peroxide, biosurfactants, and other antimicrobial metabolites.
Several studies have demonstrated that probiotic-derived CFS can inhibit Staphylococcus aureus biofilm formation and suppress the expression of virulence-associated genes, thereby reducing bacterial pathogenicity .
Surgical site infections (SSIs) represent a major healthcare burden in Egyptian hospitals, with reported prevalence rates ranging from 9% to 26% among postoperative patients .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Noha Shafik, Assistant professor
- Phone Number: 01067261504
- Email: nohasaber@med.sohag.edu.eg
Study Contact Backup
- Name: Renad Mohammed Abdelhafez, Demonstrator
- Email: Renad.Mohamed@med.sohag.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients of any age diagnosed with postoperative SSIs.
- Clinical isolates from SSIs identified as MRSA.
Exclusion Criteria:
- Any microorganism isolated from SSIs other than MRSA.
- Prior administration of postoperative antibiotics
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The effect of Probiotic cell-free supernatant (CFS) on the expression of the biofilm-associated genes icaA and fnbA in clinical MRSA isolates..
Time Frame: December 2026- to March 2027
|
December 2026- to March 2027
|
|
The number of clinical Staphylococcus aureus isolates from SSIs and determine their antimicrobial susceptibility patterns to identify methicillin-resistant Staphylococcus aureus (MRSA).
Time Frame: September 2026 to January 2027
|
September 2026 to January 2027
|
|
The effect of Probiotic cell-free supernatant (CFS) on the expression of the antibiotic resistance-associated genes mecA and femA in clinical MRSA isolates
Time Frame: March 2027 to June 2027
|
March 2027 to June 2027
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-8-19MS
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
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