Staphylococcal Aureus InfectionNCT07796555
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
An observational study of Staphylococcal Aureus Infection and Surgical Site Infection (SSI), run by Sohag University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 90 years
- Conditions the study is for
- Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
- What is being tested?
- swab from lesion, Biochemical reactions and Antibiotic sensitivity
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 2 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: wound swabs and pus specimens will be collected under complete aseptic conditions from patients with suspected SSIs using sterile swabs. The samples will be transferred immediately to the microbiology laboratory to be processed
Who may be able to join
- Patients of any age diagnosed with postoperative SSIs.
- Clinical isolates from SSIs identified as MRSA.
Who cannot join
- Any microorganism isolated from SSIs other than MRSA.
- Prior administration of postoperative antibiotics
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Renad Mohammed Abdelhafez, Demonstrator contact
About this study
Official 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
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 .
Read the 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 .
- Being tested
- swab from lesion, Biochemical reactions, Antibiotic sensitivity, Molecular detection of antibiotic resistance
- Keywords
- MRSA, Biofilm, Probiotics, Antimicrobial resistance
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swab from lesionDiagnostic 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 reactionsDiagnostic test
biochemical reactions: catalase test will be done to confirm diagnosis of Staphylococcus aureus.
Antibiotic sensitivityDiagnostic test
Antibiotic sensitivity test will be done using different antibiotics according to CLSI 2026.
Molecular detection of antibiotic resistanceDiagnostic 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Probiotic cell-free supernatant (CFS) on the expression of the biofilm-associated genes icaA and fnbA in clinical MRSA isolates..
Measured: 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).
Measured: 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
Measured: March 2027 to June 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion2 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal Aureus InfectionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renad Mohammed Abdelhafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796555
- Sponsor's protocol ID
- Soh-Med-26-8-19MS
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07796555
- Acronym / sponsor ID
- Soh-Med-26-8-19MS
- Keywords
- MRSA, Biofilm, Probiotics, Antimicrobial resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 2 Nov 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- wound swabs and pus specimens will be collected under complete aseptic conditions from patients with suspected SSIs using sterile swabs. The samples will be transferred immediately to the microbiology laboratory to be processed
Key inclusion criteria (2 listed)
- Patients of any age diagnosed with postoperative SSIs.
- Clinical isolates from SSIs identified as MRSA.
Key exclusion criteria (2 listed)
- Any microorganism isolated from SSIs other than MRSA.
- Prior administration of postoperative antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swab from lesion* 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. | Diagnostic test | – |
| Biochemical reactionsbiochemical reactions: catalase test will be done to confirm diagnosis of Staphylococcus aureus. | Diagnostic test | – |
| Antibiotic sensitivityAntibiotic sensitivity test will be done using different antibiotics according to CLSI 2026. | Diagnostic test | – |
| Molecular detection of antibiotic resistanceAssessment 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). | Diagnostic test | – |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renad Mohammed Abdelhafez, Demonstrator contact
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcal Aureus Infection and Surgical Site Infection (SSI), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Shafik, Assistant professor (01067261504, nohasaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.