NCT05751317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

February 20, 2023

Last Update Submit

April 16, 2023

Conditions

Keywords

phenotypicgenotypicEnterococcibiofilm

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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

    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.

    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

    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.

    rom December 2023 to March 2024

Study Arms (2)

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

Diagnostic Test: CultureDiagnostic Test: Staining:Diagnostic Test: Biochemical reactions:Diagnostic Test: VITEKDiagnostic Test: Antibiotic sensitivity testDiagnostic Test: nanoparticles effectDiagnostic Test: The biofilm formation activityDiagnostic Test: molecular diagnosis

samples with bacteria other than enterococci

Diagnostic Test: CultureDiagnostic Test: Staining:Diagnostic Test: Biochemical reactions:Diagnostic Test: VITEK

Interventions

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

samples containing Enterococcisamples with bacteria other than enterococci
Staining:DIAGNOSTIC_TEST

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

samples containing Enterococcisamples with bacteria other than enterococci
Biochemical reactions:DIAGNOSTIC_TEST

* Catalase test. * Salt tolerance test

samples containing Enterococcisamples with bacteria other than enterococci
VITEKDIAGNOSTIC_TEST

Automated identification of Enterococci will be done with VITEK2 system.

samples containing Enterococcisamples with bacteria other than enterococci

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

samples containing Enterococci
nanoparticles effectDIAGNOSTIC_TEST

The effect of nanoparticles on Enterococci antimicrobial resistance pattern

samples containing Enterococci

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

samples containing Enterococci
molecular diagnosisDIAGNOSTIC_TEST

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

samples containing Enterococci

Eligibility Criteria

Age1 Month - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Medicine

Sohag, 82524, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27144029BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Different 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.

MeSH Terms

Interventions

Staining and Labeling

Intervention Hierarchy (Ancestors)

Histocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative Techniques

Study Officials

  • Mona F Mohamed, professor

    Sohag University

    STUDY CHAIR
  • Wesam A Abu El wafa

    Sohag University

    STUDY CHAIR

Central Study Contacts

Mai G Abbas, Demonstrator

CONTACT

Noha S Shafik, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 2, 2023

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

March 30, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations