Pseudomonas AeruginosaPseudomonasNCT05642767
Molecular Detection Of Efflux Pump and Virulence Factors Genes in Pseudomonas Aeruginosa
An observational study of Pseudomonas Aeruginosa, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 4 weeks to 80 years
- Conditions the study is for
- Pseudomonas Aeruginosa
- What is being tested?
- culture on cetrimide agar, Staining with Gram stain and Antibiotic sensitivity testing
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 May 2023
- 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 4 weeks to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will be carried out on all patients suffering from infections that can be caused by pseudomonas aeruginosa. Samples (pus, urine, blood, sputum, ear discharge) will be collected from different departments at sohag university hospital. 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.
Who may be able to join
- All patients suffering from infections that can be caused by pseudomonas aeruginosa
Who cannot join
- Samples diagnosed to have organisms other than pseudomonas aeruginosa.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag
Noha S Shafik, lecturer, 01067261504, nohasaber@med.sohag.edu.eg
Nesma A Mohamed, Lecturer
About this study
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.
Read the detailed description
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
- Pseudomonas Aeruginosa
- Being tested
- culture on cetrimide agar, Staining with Gram stain, Antibiotic sensitivity testing, Molecular detection to efflux genes and some virulence genes
- Keywords
- Efflux genes, Pseudomonas , virulence, PCR
- Medical subject headings
- Pseudomonas Infections, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
culture on cetrimide agarDiagnostic test
Samples will be inoculated on cetrimide agar using the plating out technique.
Staining with Gram stainDiagnostic test
colonies on cetrimide agar will be spread on glass slide and stained by gram stain
Antibiotic sensitivity testingDiagnostic test
Antibiotic sensitivity testing will be done by disc diffusion method according to CLSI
Molecular detection to efflux genes and some virulence genesDiagnostic test
Molecular detection to efflux genes and some virulence genes by conventional PCR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: culture on cetrimide agar; Diagnostic Test: Staining with Gram stain; Diagnostic Test: Antibiotic sensitivity testing; Diagnostic Test: Molecular detection to efflux genes and some virulence genes | |
| 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. Receives: Diagnostic Test: culture on cetrimide agar; Diagnostic Test: Staining with Gram stain; Diagnostic Test: Antibiotic sensitivity testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isolation and identification of pseudomonas aeruginosa using culture and automated system techniques
identification of pseudomonas aeruginosa in different clinical samples collected from Sohag University hospital using different laboratory techniques as culture on citramide agar, Staining with Gram, biochemical reactions such as Oxidase test, sugar fermentation test, and automated identification using vitek2 system
Measured: 1 December 2022 to 1 February 2023
Identification of recent antibiotic sensitivity pattern using Modified Kerby -Disc Diffusion method
Determination of recent antibiotic sensitivity pattern using different antibiotics by disc diffusion method by spreading the inoculum in pitry dish containing Muller Hinton Agar, then different discs containing antibiotics are placed at a distance of 1.5 cm, then incubated at 37 co for 24 hrs. The diameter of the zone of inhibition is measured to determine MIC for each antibiotic according to the guidelines of CSLI 2022.
Measured: 1 December 2022 to 1 February 2023
Molecular Identification of some virulence factors and efflux genes using PCR
Molecular detection of some virulence factors and efflux genes using specific primers by conventional PCR. primers of the following genes will be used as exoS,exoU, toxA, mex A, mex B. Extraction of DNA will be done first, followed by amplification technique using the thermal cycler. Detection of amplified DNA will be done using Agrose gel electrophoresis stained with ethidium bromide.
Measured: 1 February 2023 to 30 March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022
- Primary completion30 Mar 2023
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudomonas AeruginosaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Saber Shafik, Sohag University
- Investigators
- Mohamed H Alrawy, Study chair, Faculty of medicine, Sohag universityEbtisam M Gad, Study chair, Faculty Of Medicine, Sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642767
- Sponsor's protocol ID
- Soh-Med-22-11-18
- Acronym
- Pseudomonas
- Status last verified
- Apr 2023
- First submitted
- 19 Nov 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Detection Of Efflux Pump and Virulence Factors Genes in Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT05642767
- Acronym / sponsor ID
- Pseudomonas / Soh-Med-22-11-18
- Conditions
- Pseudomonas Aeruginosa
- Keywords
- Efflux genes, Pseudomonas , virulence, PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 8 Dec 2022 (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.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with pseudomonas aeruginosa infections | – | Diagnostic Test: culture on cetrimide agar, Diagnostic Test: Staining with Gram stain, Diagnostic Test: Antibiotic sensitivity testing, Diagnostic Test: Molecular detection to efflux genes and some virulence genesAll 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. |
| Patients with infections other than pseudomonas aeruginosa | – | Diagnostic Test: culture on cetrimide agar, Diagnostic Test: Staining with Gram stain, Diagnostic Test: Antibiotic sensitivity testing* 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. |
Who may qualify
- Ages
- 4 weeks to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be carried out on all patients suffering from infections that can be caused by pseudomonas aeruginosa. Samples (pus, urine, blood, sputum, ear discharge) will be collected from different departments at sohag university hospital. 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.
Key inclusion criteria (1 listed)
- All patients suffering from infections that can be caused by pseudomonas aeruginosa
Key exclusion criteria (1 listed)
- Samples diagnosed to have organisms other than pseudomonas aeruginosa.
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 on cetrimide agarSamples will be inoculated on cetrimide agar using the plating out technique. | Diagnostic test | Patients with infections other than pseudomonas aeruginosa, Patients with pseudomonas aeruginosa infections |
| Staining with Gram staincolonies on cetrimide agar will be spread on glass slide and stained by gram stain | Diagnostic test | Patients with infections other than pseudomonas aeruginosa, Patients with pseudomonas aeruginosa infections |
| Antibiotic sensitivity testingAntibiotic sensitivity testing will be done by disc diffusion method according to CLSI | Diagnostic test | Patients with infections other than pseudomonas aeruginosa, Patients with pseudomonas aeruginosa infections |
| Molecular detection to efflux genes and some virulence genesMolecular detection to efflux genes and some virulence genes by conventional PCR | Diagnostic test | Patients with pseudomonas aeruginosa infections |
Primary outcome
Isolation and identification of pseudomonas aeruginosa using culture and automated system techniques
Time frame: 1 December 2022 to 1 February 2023
identification of pseudomonas aeruginosa in different clinical samples collected from Sohag University hospital using different laboratory techniques as culture on citramide agar, Staining with Gram, biochemical reactions such as Oxidase test, sugar fermentation test, and automated identification using vitek2 system
Identification of recent antibiotic sensitivity pattern using Modified Kerby -Disc Diffusion method
Time frame: 1 December 2022 to 1 February 2023
Determination of recent antibiotic sensitivity pattern using different antibiotics by disc diffusion method by spreading the inoculum in pitry dish containing Muller Hinton Agar, then different discs containing antibiotics are placed at a distance of 1.5 cm, then incubated at 37 co for 24 hrs. The diameter of the zone of inhibition is measured to determine MIC for each antibiotic according to the guidelines of CSLI 2022.
Molecular Identification of some virulence factors and efflux genes using PCR
Time frame: 1 February 2023 to 30 March 2023
Molecular detection of some virulence factors and efflux genes using specific primers by conventional PCR. primers of the following genes will be used as exoS,exoU, toxA, mex A, mex B. Extraction of DNA will be done first, followed by amplification technique using the thermal cycler. Detection of amplified DNA will be done using Agrose gel electrophoresis stained with ethidium bromide.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mohamed H Alrawy study chair
Faculty of medicine, Sohag university
Ebtisam M Gad study chair
Faculty Of Medicine, 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 Pseudomonas Aeruginosa, 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 12 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 Noha S Shafik, lecturer (01067261504 ext. +20, Nohasaber@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 pseudomonas aeruginosa using culture and automated system techniques (time frame: 1 December 2022 to 1 February 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.