Molecular Detection Of Efflux Pump and Virulence Factors Genes in Pseudomonas Aeruginosa

NCT ID: NCT05642767

Last Updated: 2023-04-12

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

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-05-01

Brief Summary

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

Pseudomonas aeruginosa (PA) is a ubiquitous aerobic, non-fermentative Gram-negative rod that is widely associated with nosocomial pneumonia and can lead to severe illness with poor outcomes, particularly in critically ill people due to the ability of some strains to cause lung epithelial injury and spread into the circulation. 2 In the intensive care unit, PA infection is ranked among the top five causes of the bloodstream, pulmonary, surgical site, urinary tract, and soft tissue infections.

Detailed Description

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

The pathogenesis of PA infections is multifactorial, and it is frequently complicated by the bacteria's intrinsic resistance to some antimicrobial agents such as sulfonamides, tetracyclines, and trimethoprim, as well as its ability to acquire or quickly develop resistance to major classes of antibiotics such as aminoglycosides, quinolones, B-lactams, and polymyxins (Bassetti et al., 2018).

The efflux systems, which mediate the expulsion of antibiotics out of the cell shortly after entry, the production of enzymes to inactivate antibiotics, and the decrease in permeability across the cell wall are some mechanisms used by PA to develop antimicrobial resistance (Meletis \& Bagkeri, 2013).

PA possesses a large number of virulence factors that play a significant role in pathogenesis and the determination of infection severity. These virulence factors act alone or in synergy with each other to cause tissue damage, necrosis, and cell death. Among the virulence factors of PA, the major determinants of virulence are the type III secretion system (T3SS) and quorum sensing (cell-to-cell signaling system). The T3SS is a needle-like complex, also known as the injectisome, that enables a bacterium to deliver different effector proteins such as ExoS, ExoT, ExoU, and ExoY across the membrane into a host cell, altering host cell functions and increasing bacterial survival rates ( Horna G and, Ruiz J, 2021). In this study, we aimed to evaluate the prevalence of antibiotic resistance caused by the presence of Efflux genes and some virulence factors in Pseudomonas aeruginosa from clinical isolates.

Conditions

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

Pseudomonas Aeruginosa

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.

Patients with pseudomonas aeruginosa infections

All patients suffer from infections that can be caused by pseudomonas aeruginosa.

Clinical Data will be obtained as:

* Data about clinical manifestations including fever, expectoration, pus from wounds, urinary symptoms, symptoms of upper respiratory tract infections, and symptoms of otitis externa.
* Samples will be cultured on cetrimide agar.
* Antibiotic sensitivity testing will be done by disc diffusion method according to CLSI.
* Molecular detection to efflux genes and some virulence genes by PCR.

culture on cetrimide agar

Intervention Type DIAGNOSTIC_TEST

Samples will be inoculated on cetrimide agar using the plating out technique.

Staining with Gram stain

Intervention Type DIAGNOSTIC_TEST

colonies on cetrimide agar will be spread on glass slide and stained by gram stain

Antibiotic sensitivity testing

Intervention Type DIAGNOSTIC_TEST

Antibiotic sensitivity testing will be done by disc diffusion method according to CLSI

Molecular detection to efflux genes and some virulence genes

Intervention Type DIAGNOSTIC_TEST

Molecular detection to efflux genes and some virulence genes by conventional PCR

Patients with infections other than pseudomonas aeruginosa

* Data about clinical manifestations including fever, expectoration, pus from wounds, urinary symptoms, symptoms of upper respiratory tract infections, and symptoms of otitis externa.
* Samples will be cultured on different culture media and automated identification by Vitek system.

culture on cetrimide agar

Intervention Type DIAGNOSTIC_TEST

Samples will be inoculated on cetrimide agar using the plating out technique.

Staining with Gram stain

Intervention Type DIAGNOSTIC_TEST

colonies on cetrimide agar will be spread on glass slide and stained by gram stain

Antibiotic sensitivity testing

Intervention Type DIAGNOSTIC_TEST

Antibiotic sensitivity testing will be done by disc diffusion method according to CLSI

Interventions

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

culture on cetrimide agar

Samples will be inoculated on cetrimide agar using the plating out technique.

Intervention Type DIAGNOSTIC_TEST

Staining with Gram stain

colonies on cetrimide agar will be spread on glass slide and stained by gram stain

Intervention Type DIAGNOSTIC_TEST

Antibiotic sensitivity testing

Antibiotic sensitivity testing will be done by disc diffusion method according to CLSI

Intervention Type DIAGNOSTIC_TEST

Molecular detection to efflux genes and some virulence genes

Molecular detection to efflux genes and some virulence genes by conventional 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 pseudomonas aeruginosa

Exclusion Criteria

* Samples diagnosed to have organisms other than pseudomonas aeruginosa.
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

80 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.

Noha Saber Shafik

lecturer of Medical Microbiology and Immunology, faculty of medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Mohamed H Alrawy

Role: STUDY_CHAIR

Faculty of medicine, Sohag university

Ebtisam M Gad

Role: STUDY_CHAIR

Faculty Of Medicine, Sohag university

Locations

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

Sohag University

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.

Noha S Shafik, lecturer

Role: CONTACT

01067261504 ext. +20

Nesma A Mohammed, lecturer

Role: CONTACT

01006780725 ext. +20

Facility Contacts

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

Noha S Shafik, lecturer

Role: primary

01067261504

Nesma A Mohamed, Lecturer

Role: backup

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

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

Soh-Med-22-11-18

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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