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NCT Number: NCT07796555

Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus

Staphylococcus aureus are Gram-positive cocci that asymptomatically colonize the skin and mucosal surfaces of approximately 20-30% of healthy individuals . Although they commonly exist as a harmless commensal organisms, S. aureus are one of the most clinically significant opportunistic pathogens, causing a wide range of community and healthcare-associated infections. These infections vary from superficial skin and soft tissue infections to severe invasive diseases, including bacteremia, infective endocarditis, pneumonia, osteomyelitis, and device-associated infections .

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Key information

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

swab from lesion

Diagnostic Test
  • Direct smear with Gram stain to identify the morphology of Staphylococcus aureus.
  • culture of the samples on different culture media such as nutrient agar, blood agar, and Mannitol salt agar.

Biochemical reactions

Diagnostic Test

biochemical reactions: catalase test will be done to confirm diagnosis of Staphylococcus aureus.

antibiotic sensitivity

Diagnostic Test

Antibiotic sensitivity test will be done using different antibiotics according to CLSI 2026.

Molecular detection of antibiotic resistance

Diagnostic Test

Assessment of the expression of selected biofilm-related genes (icaA and fnbA) and antibiotic resistance-related genes (mecA and femA) using quantitative real-time PCR (qRT-PCR) before and after treatment with probiotic cell-free supernatant (CFS).

Primary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Noha Shafik, Assistant professor

CONTACT

[email protected]

01067261504

Renad Mohammed Abdelhafez, Demonstrator

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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