Phenotypic and Genotypic Variations of Enterococcus Spp

NCT ID: NCT05751317

Last Updated: 2023-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

samples containing Enterococci

Isolates of Enterococci will be identified by Gram staining, colony morphology, catalase test, and growth on Bile Esculin agar. All isolates will be identified to species level using Vitek2 automated system Strains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on MuellerHinton Agar.

The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique Detection of the effect of nanoparticles on the antibiotic susceptibility profile of Enterococci. Detection of the effect of nanoparticles on the biofilm producing Enterococci. Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using PCR

Culture

Intervention Type DIAGNOSTIC_TEST

* Samples will be transported to Medical Microbiology and Immunology Laboratory and will be inoculated on MacConkey medium.
* Pink colonies will be inoculated on bile esculin agar medium.
* Enterococci produce blackening of the agar

Staining:

Intervention Type DIAGNOSTIC_TEST

The growing colonies on bile esculin agar medium will be examined microscopically after staining by Gram stain.

Biochemical reactions:

Intervention Type DIAGNOSTIC_TEST

* Catalase test.
* Salt tolerance test

VITEK

Intervention Type DIAGNOSTIC_TEST

Automated identification of Enterococci will be done with VITEK2 system.

Antibiotic sensitivity test

Intervention Type DIAGNOSTIC_TEST

Strains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on Mueller-Hinton Agar.

nanoparticles effect

Intervention Type DIAGNOSTIC_TEST

The effect of nanoparticles on Enterococci antimicrobial resistance pattern

The biofilm formation activity

Intervention Type DIAGNOSTIC_TEST

The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique

molecular diagnosis

Intervention Type DIAGNOSTIC_TEST

Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using PCR

samples with bacteria other than enterococci

Culture

Intervention Type DIAGNOSTIC_TEST

* Samples will be transported to Medical Microbiology and Immunology Laboratory and will be inoculated on MacConkey medium.
* Pink colonies will be inoculated on bile esculin agar medium.
* Enterococci produce blackening of the agar

Staining:

Intervention Type DIAGNOSTIC_TEST

The growing colonies on bile esculin agar medium will be examined microscopically after staining by Gram stain.

Biochemical reactions:

Intervention Type DIAGNOSTIC_TEST

* Catalase test.
* Salt tolerance test

VITEK

Intervention Type DIAGNOSTIC_TEST

Automated identification of Enterococci will be done with VITEK2 system.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Culture

* Samples will be transported to Medical Microbiology and Immunology Laboratory and will be inoculated on MacConkey medium.
* Pink colonies will be inoculated on bile esculin agar medium.
* Enterococci produce blackening of the agar

Intervention Type DIAGNOSTIC_TEST

Staining:

The growing colonies on bile esculin agar medium will be examined microscopically after staining by Gram stain.

Intervention Type DIAGNOSTIC_TEST

Biochemical reactions:

* Catalase test.
* Salt tolerance test

Intervention Type DIAGNOSTIC_TEST

VITEK

Automated identification of Enterococci will be done with VITEK2 system.

Intervention Type DIAGNOSTIC_TEST

Antibiotic sensitivity test

Strains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on Mueller-Hinton Agar.

Intervention Type DIAGNOSTIC_TEST

nanoparticles effect

The effect of nanoparticles on Enterococci antimicrobial resistance pattern

Intervention Type DIAGNOSTIC_TEST

The biofilm formation activity

The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique

Intervention Type DIAGNOSTIC_TEST

molecular diagnosis

Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Month

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mai Gamal Abdel Naser Abbas Khalifa

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mona F Mohamed, professor

Role: STUDY_CHAIR

Sohag University

Wesam A Abu El wafa

Role: STUDY_CHAIR

Sohag University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty Of Medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mai G Abbas, Demonstrator

Role: CONTACT

01068298408

Noha S Shafik, Lecturer

Role: CONTACT

01067261504

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mai G Abdelnaser, demonstrator

Role: primary

00201068298408

Noha S Shafik, Lecturer

Role: backup

00201067261504

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27144029 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Soh-Med-23-02-10

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.