Isolation of Enterococci From SamplesNCT05751317
Phenotypic and Genotypic Variations of Enterococcus Spp
An observational study of Isolation of Enterococci From Samples and Demonstration of Enterococci Antibiotic Susceptibility, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 90 years
- Conditions the study is for
- Isolation of Enterococci From Samples, Demonstration of Enterococci Antibiotic Susceptibility, Detection of Strains Enterococci Produce Biofilm
- What is being tested?
- Culture, Staining: and Biochemical reactions:
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 90 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- All patients suffering from infections that can be caused by Enterococci.
Who cannot join
- All patients suffering from infections that aren't caused by Enterococci
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Medicine
Sohag, 82524
Mai G Abdelnaser, demonstrator, 00201068298408, maigamal@med.sohag.edu.eg
Noha S Shafik, Lecturer, 00201067261504, nohasaber@med.sohag.edu.eg
About this study
Official title: Phenotypic and Genotypic Variations of Enterococcus Spp. Isolated From Patients With Hospital Acquired Infections in Sohag University Hospitals, Egypt
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.
Read the 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.
- 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
- Being tested
- Culture, Staining:, Biochemical reactions:, VITEK, Antibiotic sensitivity test
- Keywords
- phenotypic, genotypic, Enterococci, biofilm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CultureDiagnostic 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:Diagnostic test
The growing colonies on bile esculin agar medium will be examined microscopically after staining by Gram stain.
Biochemical reactions:Diagnostic test
- Catalase test.
- Salt tolerance test
VITEKDiagnostic test
Automated identification of Enterococci will be done with VITEK2 system.
Antibiotic sensitivity testDiagnostic 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 effectDiagnostic test
The effect of nanoparticles on Enterococci antimicrobial resistance pattern
The biofilm formation activityDiagnostic test
The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique
molecular diagnosisDiagnostic test
Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using PCR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Culture; Diagnostic Test: Staining:; Diagnostic Test: Biochemical reactions:; Diagnostic Test: VITEK; Diagnostic Test: Antibiotic sensitivity test; Diagnostic Test: nanoparticles effect; Diagnostic Test: The biofilm formation activity; Diagnostic Test: molecular diagnosis | |
| samples with bacteria other than enterococci | Not described Receives: Diagnostic Test: Culture; Diagnostic Test: Staining:; Diagnostic Test: Biochemical reactions:; Diagnostic Test: VITEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and identification of Enterococci from different clinical samples
Isolation and identification of Enterococci from different clinical samples (pus, urine, urinary catheter samples, stool, wound swabs, sputum, central venous catheter samples) will be collected under aseptic precautions from patients admitted at different departments at Sohag university hospitals.
Measured: from April 2023 to December 2023
Demonstration of Enterococci antibiotic susceptibility profile
Strains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on Mueller-Hinton Agar.
Measured: from April 2023 to December 2023
Detection of strains of Enterococci which produce biofilm
The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique
Measured: from April 2023 to December 2023
Studying the effect of nanoparticles on Enterococci antimicrobial resistance pattern
Inhibition zones of all groups will be compared to detect the effect of nanoparticles on Enterococci antimicrobial resistance pattern.
Measured: from April 2023 to December 2023
Studying the effect of nanoparticles on Enterococci biofilm producing ability
The effect of nanoparticles on Enterococci biofilm producing ability
Measured: from December 2023 to March 2024
Genotypic characterization of Enterococci.
Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using polymerase chain reaction.
Measured: rom December 2023 to March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Isolation of Enterococci From SamplesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Gamal Abdel Naser Abbas Khalifa, Sohag University
- Investigators
- Mona F Mohamed, professor, Study chair, Sohag UniversityWesam A Abu El wafa, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751317
- Sponsor's protocol ID
- Soh-Med-23-02-10
- Status last verified
- Apr 2023
- First submitted
- 20 Feb 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27144029
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Variations of Enterococcus Spp. Isolated From Patients With Hospital Acquired Infections in Sohag University Hospitals, Egypt
- ClinicalTrials.gov ID
- NCT05751317
- Acronym / sponsor ID
- Soh-Med-23-02-10
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 2 Mar 2023 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| samples containing Enterococci | – | Diagnostic Test: Culture, Diagnostic Test: Staining:, Diagnostic Test: Biochemical reactions:, Diagnostic Test: VITEK, Diagnostic Test: Antibiotic sensitivity test, Diagnostic Test: nanoparticles effect, Diagnostic Test: The biofilm formation activity, Diagnostic Test: molecular diagnosisIsolates 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 |
| samples with bacteria other than enterococci | – | Diagnostic Test: Culture, Diagnostic Test: Staining:, Diagnostic Test: Biochemical reactions:, Diagnostic Test: VITEK |
Who may qualify
- Ages
- 1 month to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients suffering from infections that can be caused by Enterococci.
Key exclusion criteria (1 listed)
- All patients suffering from infections that aren't caused by Enterococci
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 |
|---|---|---|
| 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 | Diagnostic test | samples containing Enterococci, samples with bacteria other than enterococci |
| Staining:The growing colonies on bile esculin agar medium will be examined microscopically after staining by Gram stain. | Diagnostic test | samples containing Enterococci, samples with bacteria other than enterococci |
| Biochemical reactions:* Catalase test. * Salt tolerance test | Diagnostic test | samples containing Enterococci, samples with bacteria other than enterococci |
| VITEKAutomated identification of Enterococci will be done with VITEK2 system. | Diagnostic test | samples containing Enterococci, samples with bacteria other than enterococci |
| Antibiotic sensitivity testStrains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on Mueller-Hinton Agar. | Diagnostic test | samples containing Enterococci |
| nanoparticles effectThe effect of nanoparticles on Enterococci antimicrobial resistance pattern | Diagnostic test | samples containing Enterococci |
| The biofilm formation activityThe biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique | Diagnostic test | samples containing Enterococci |
| molecular diagnosisMolecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using PCR | Diagnostic test | samples containing Enterococci |
Primary outcome
Isolation and identification of Enterococci from different clinical samples
Time frame: from April 2023 to December 2023
Isolation and identification of Enterococci from different clinical samples (pus, urine, urinary catheter samples, stool, wound swabs, sputum, central venous catheter samples) will be collected under aseptic precautions from patients admitted at different departments at Sohag university hospitals.
Demonstration of Enterococci antibiotic susceptibility profile
Time frame: from April 2023 to December 2023
Strains confirmed as Enterococci will be examined for their antibiotic susceptibility by modified Kirby Bauer's disc diffusion method on Mueller-Hinton Agar.
Detection of strains of Enterococci which produce biofilm
Time frame: from April 2023 to December 2023
The biofilm formation activity of Enterococci isolates will be tested using the microtiter plate technique
Studying the effect of nanoparticles on Enterococci antimicrobial resistance pattern
Time frame: from April 2023 to December 2023
Inhibition zones of all groups will be compared to detect the effect of nanoparticles on Enterococci antimicrobial resistance pattern.
Studying the effect of nanoparticles on Enterococci biofilm producing ability
Time frame: from December 2023 to March 2024
The effect of nanoparticles on Enterococci biofilm producing ability
Genotypic characterization of Enterococci.
Time frame: rom December 2023 to March 2024
Molecular identification of some virulence factors genes and antibiotic resistance genes of Enterococci using polymerase chain reaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Background: PubMed 27144029Ferguson 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.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Mona F Mohamed, professor study chair
Sohag University
Wesam A Abu El wafa study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Isolation of Enterococci From Samples and Demonstration of Enterococci Antibiotic Susceptibility, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai G Abbas, Demonstrator (01068298408, maigamal@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isolation and identification of Enterococci from different clinical samples (time frame: from April 2023 to December 2023). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05751317, which also lists 1 linked publication.
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 19 Apr 2023.