Clinical trial NCT05751317: Phenotypic and Genotypic Variations of Enterococcus Spp
Official title: Phenotypic and Genotypic Variations of Enterococcus Spp. Isolated From Patients With Hospital Acquired Infections in Sohag University Hospitals, Egypt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Isolation of Enterococci From Samples
Demonstration of Enterococci Antibiotic Susceptibility
Detection of Strains Enterococci Produce Biofilm
Studying Effect of Nanoparticles on Enterococci Antimicrobial Resistance
Studying Effect of Nanoparticles on Enterococci Biofilm
Genotyping of Enterococci
Keywords: phenotypic
genotypic
Enterococci
biofilm
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the selected patients will be subjected to complete history taking (personal, clinical, associated comorbidities, history of drug intake, and length of hospital stay before sampling).

\* Collected samples will be transported to the Medical Microbiology and Immunology research laboratory as soon as possible.

Brief summary: Enterococci are Gram-positive facultative anaerobic cocci arranged in short and medium chains. Enterococci reside in the gastrointestinal tract and usually function commensally with humans. They can, however, cause several infections, such as urinary tract infections (UTIs), intra-abdominal infection, bacteremia, or endocarditis.

Among many species identified, E. faecalis and E. faecium are the most common species capable of causing infection and posing a threat of antimicrobial resistance, with E. faecalis accounting for the majority of infections.

Detailed description: Enterococci are Gram-positive facultative anaerobic cocci arranged in short and medium chains.

Enterococci reside in the gastrointestinal tract and usually function commensally with humans. They can, however, cause several infections, such as urinary tract infections (UTIs), intra-abdominal infection, bacteremia, or endocarditis.

Among many species identified, E. faecalis and E. faecium are the most common species capable of causing infection and posing a threat of antimicrobial resistance, with E. faecalis accounting for the majority of infections.

Pathogenic species of enterococci express many virulence factors such as adhesins, gelatinase, Enterococcus surface protein, aggregation substances and cytolysins along with biofilm formation. These factors enhance the ability of the pathogen to invade, attach and survive through the acquisition of nutrients in the host tissue. Their presence in drug resistant strains increases the severity of the infection

Enterococci are intrinsically resistant to antibiotics such as aminoglycosides and β-lactam-based antibiotics. Moderate resistance to aminoglycosides is due to the intrinsic low permeability of the enterococcal cell wall to the large aminoglycoside molecules and is more prevalent in E. faecium than E. faecalis. Intrinsic β-lactam resistance is due to the overexpression of penicillin-binding proteins with low affinity for β-lactams, which makes E. faecalis more resistant to penicillin than E. faecium

Moreover, enterococci can readily acquire resistance to antimicrobials, and vancomycin-resistant enterococci (VRE) are among the priority pathogens for which new antibiotics are needed.

In addition, biofilm formation is one of the strategies for the enterococci to evade the host's immune response and the inhibitory or killing effects of antibiotics.

This self-produced extracellular matrix also provides a suitable microenvironment for enterococci to grow and facilitates the transmission of mobile genetic elements (MGEs) between bacteria. Enterococcal biofilms have been implicated in indwelling device-related infections such as prosthetic valve endocarditis, prosthetic joint infections and catheter-related infections.

Biofilm forming bacteria show resistance to many antibiotics and immune response which results in treatment failure. Given the difficulty of treating and eradicating biofilm associated infections, there is an unmet need for therapeutic options other than antibiotics to prevent biofilm formation.

Nanoparticles are attracting attention given their very small size and various antibacterial properties. Nanoparticles can interact with bacteria per unit area, which can make the antibacterial activity of nanoparticles more powerful. Nanoparticles can also initiate several bactericidal pathways, such as disrupting the bacterial membrane and release of intracellular components, making it difficult for bacteria to become resistant.

Eligibility criteria: Inclusion Criteria:

* All patients suffering from infections that can be caused by Enterococci.

Exclusion Criteria:

* All patients suffering from infections that aren't caused by Enterococci

Primary outcomes:
measure: Isolation and identification of Enterococci from different clinical samples
timeFrame: from April 2023 to December 2023
measure: Demonstration of Enterococci antibiotic susceptibility profile
timeFrame: from April 2023 to December 2023
measure: Detection of strains of Enterococci which produce biofilm
timeFrame: from April 2023 to December 2023
measure: Studying the effect of nanoparticles on Enterococci antimicrobial resistance pattern
timeFrame: from April 2023 to December 2023
measure: Studying the effect of nanoparticles on Enterococci biofilm producing ability
timeFrame: from December 2023 to March 2024
measure: Genotypic characterization of Enterococci.
timeFrame: rom December 2023 to March 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty Of Medicine
Study officials:
affiliation: Sohag University
name: Mona F Mohamed, professor
role: STUDY_CHAIR
affiliation: Sohag University
name: Wesam A Abu El wafa
role: STUDY_CHAIR
References:
citation: Ferguson DM, Talavera GN, Hernandez LA, Weisberg SB, Ambrose RF, Jay JA. Virulence Genes among Enterococcus faecalis and Enterococcus faecium Isolated from Coastal Beaches and Human and Nonhuman Sources in Southern California and Puerto Rico. J Pathog. 2016;2016:3437214. doi: 10.1155/2016/3437214. Epub 2016 Apr 10.