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Not yet recruitingNCT07796555Updated Sep 1, 2026

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

An observational study in Staphylococcal Aureus Infection and Surgical Site Infection (SSI), sponsored by Sohag University. Not yet recruiting. Open to participants aged 6 Months to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Sohag University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
6 Months to 90 Years
Sex
All
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Study 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. 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 .

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Conditions studied

  • Staphylococcal Aureus Infection
  • Surgical Site Infection (SSI)

Keywords

  • MRSA
  • Biofilm
  • Probiotics
  • Antimicrobial resistance
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In context

Surgical Wound Infection

746 studies on the registry are indexed under Surgical Wound Infection; 152 are open to participants now.

This study's planned enrollment of 100 is below the median of 239 across 135 observational studies indexed under Surgical Wound Infection.

Browse Surgical Wound Infection studies →

Lead sponsor

Sohag University is the lead sponsor of 1,232 studies on the registry; 638 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients of any age diagnosed with postoperative SSIs.
  • Clinical isolates from SSIs identified as MRSA.

Exclusion criteria

Exclusion Criteria:

  • Any microorganism isolated from SSIs other than MRSA.
  • Prior administration of postoperative antibiotics
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Diagnostic testswab 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 testBiochemical reactions

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

  • Diagnostic testAntibiotic sensitivity

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

  • Diagnostic testMolecular detection of antibiotic resistance

    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).

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Related links

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2027, 11 months later.

Of 65 non-industry observational studies under Surgical Wound Infection, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 53. This study's planned 11 months is below that.

Counting every sponsor, half of 68 studies reached it within 21 months; a quarter within 9 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Sep 1, 2026
StartEst.
Sep 20, 2026
Primary completionEst.
Aug 30, 2027
CompletionEst.
Nov 2, 2027
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07796555
Lead sponsor
Sohag University
Responsible party
Renad Mohammed Abdelhafez (Demonstrator of Medical microbiology and Immunology, Sohag University) — Principal investigator
First posted
Sep 1, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Aug 30, 2027 (estimated)
Completion
Nov 2, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

Noha Shafik, Assistant professor
Contact
nohasaber@med.sohag.edu.eg
01067261504
Renad Mohammed Abdelhafez, Demonstrator
Contact
Renad.Mohamed@med.sohag.edu.eg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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