- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469436
mexB Efflux Pump Gene Expression, Activity and Biofilm Formation in Clinical Isolates of Pseudomonas Aeruginosa
March 14, 2026 updated by: Rehab Abdelnasser Mohammed Omran, Assiut University
Relationship Between mexB Efflux Pump Gene Expression, Efflux Pump Activity and Biofilm Formation in Multidrug Resistant Clinical Isolates of Pseudomonas Aeruginosa
- Detection of expression level of mexB efflux pump gene in multidrug resistant clinical isolates of Pseudomonas aeruginosa by real time PCR(QRT-PCR).
- Phenotypic detection of efflux pump activity in multidrug resistant clinical isolates of Pseudomonas aeruginosa.
- Phenotypic detection of biofilm formation and its degree (strong-moderate-weak) in multidrug resistant clinical isolates of Pseudomonas aeruginosa.
- Relationship between expression level of mexB efflux pump gene and degree of biofilm formation in multidrug resistant clinical isolates of Pseudomonas aeruginosa.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Pseudomonas aeruginosa is an opportunistic gram-negative pathogen, causing life threatening nosocomial infections including respiratory system, urinary system and skin wounds (1).
P. aeruginosa exhibits resistance to a range of antibiotic classes, including aminoglycosides, carbapenems, beta-lactams, quinolones, and cephalosporins (2).
Frequent occurrence of drug resistance is due to many virulence factors in P. aeruginosa such as flagella, pili, lipopolysaccharides, secreted enzymes like DNase and lipase, toxins, and pigments as pyocyanin which play crucial roles in tissue damage and immune suppression.
Multiple resistant mechanisms are developed by P. aeruginosa (3).
Two prominent mechanisms, biofilm formation and efflux pump activity among other mechanisms, play an important role in persistence and antibiotic resistance (4).
Biofilm formation produced by P. aeruginosa is a complex phenomenon that promotes antibiotic resistance and shields the pathogen from the host immune system.
This results in severe clinical outcomes in critically ill patients (5).
There are about 12 resistance-nodulation-division (RND) families of efflux pumps in P. aeruginosa.
The mexAB-oprM multidrug efflux pump system of P. aeruginosa is involved in resistance (6).
Efflux pumps play a role in biofilm formation by influencing Physical-chemical interactions, mobility, gene regulation, quorum sensing (QS), extracellular polymeric substances (EPS), and toxic compound extrusion (6)(7).
It has been demonstrated that MexAB-OprM plays a role in the resistance of aztreonam, gentamicin, tetracycline and tobramycin in biofilm structures of P. aeruginosa (8).
MexB is the most critical and specific gene for efflux activity within the MexAB-OprM system and contributes to antibiotic resistance in Pseudomonas aeruginosa (9).
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rehab AM Omran
- Phone Number: 01025113833
- Email: remy25.1994rn@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with multidrug resistant clinical isolates of Pseudomonas aeruginosa.
Description
Inclusion Criteria:
- Clinical isolates confirmed as Pseudomonas aeruginosa by microbiological testing.
- Isolates collected from different clinical specimens (e.g., wound swabs, sputum, urine, blood, and catheters).
Exclusion Criteria:
- Bacterial species other than Pseudomonas aeruginosa.
- Repeated clinical isolates from the same patient.
- Repeated clinical specimens from different sources of the same patient.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of mexB efflux pump gene expression level in multidrug resistant clinical isolates of Pseudomonas aeruginosa
Time Frame: one year
|
molecular detection of mexB efflux pump gene expression level by real time PCR (QRT-PCR)
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of efflux pump activity in multidrug resistant clinical isolates of Pseudomonas aeruginosa
Time Frame: one year
|
Phenotypic detection of efflux pump activity by MIC (minimal inhibitory concentration) testing with efflux pump inhibitors (EPIs) using Phenylalanine-arginine β-naphthylamide (PAβN)in P. aeruginosa
|
one year
|
|
Detection of degree of biofilm formation (strong-moderate-weak) in multidrug resistant clinical isolates of Pseudomonas aeruginosa
Time Frame: one year
|
Phenotypic detection of biofilm formation using microtiter plate assay and assess the degree of biofilm (strong-moderate-weak)
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Assiut University, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Li XF, Shi HQ, Liang Y, Li J, Jiang B, Song GB. Interaction of biofilm and efflux pump in clinical isolates of carbapenem resistant P. aeruginosa. Eur Rev Med Pharmacol Sci. 2022 Mar;26(5):1729-1737. doi: 10.26355/eurrev_202203_28242.
- Soltani Borchaloee A, Moosakazemi Mohammadi LS, Khosh Ravesh R, Allameh SF, Tabatabaie Poya FS, Fatehi MA. Prevalence of Biofilm and Efflux Pump Genes Expression by PCR and Antibiotic Resistance Pattern in Pseudomonas Aeruginosa. Arch Razi Inst. 2024 Dec 31;79(6):1281-1286. doi: 10.32592/ARI.2024.79.6.1281. eCollection 2024 Dec.
- Liao C, Huang X, Wang Q, Yao D, Lu W. Virulence Factors of Pseudomonas Aeruginosa and Antivirulence Strategies to Combat Its Drug Resistance. Front Cell Infect Microbiol. 2022 Jul 6;12:926758. doi: 10.3389/fcimb.2022.926758. eCollection 2022.
- Ugwuanyi FC, Ajayi A, Ojo DA, Adeleye AI, Smith SI. Evaluation of efflux pump activity and biofilm formation in multidrug resistant clinical isolates of Pseudomonas aeruginosa isolated from a Federal Medical Center in Nigeria. Ann Clin Microbiol Antimicrob. 2021 Feb 2;20(1):11. doi: 10.1186/s12941-021-00417-y.
- Karballaei Mirzahosseini H, Hadadi-Fishani M, Morshedi K, Khaledi A. Meta-Analysis of Biofilm Formation, Antibiotic Resistance Pattern, and Biofilm-Related Genes in Pseudomonas aeruginosa Isolated from Clinical Samples. Microb Drug Resist. 2020 Jul;26(7):815-824. doi: 10.1089/mdr.2019.0274. Epub 2020 Jan 23.
- Hajiagha MN, Kafil HS. Efflux pumps and microbial biofilm formation. Infect Genet Evol. 2023 Aug;112:105459. doi: 10.1016/j.meegid.2023.105459. Epub 2023 Jun 2.
- Ren J, Wang M, Zhou W, Liu Z. Efflux pumps as potential targets for biofilm inhibition. Front Microbiol. 2024 Feb 23;15:1315238. doi: 10.3389/fmicb.2024.1315238. eCollection 2024.
- Soto SM. Role of efflux pumps in the antibiotic resistance of bacteria embedded in a biofilm. Virulence. 2013 Apr 1;4(3):223-9. doi: 10.4161/viru.23724. Epub 2013 Feb 4.
- Habib MB, Shah NA, Amir A, Alghamdi HA, Tariq MH, Nisa K, Ammoun M. Decoding MexB efflux pump genes: structural, molecular, and phylogenetic analysis of multidrug-resistant and extensively drug-resistant Pseudomonas aeruginosa. Front Cell Infect Microbiol. 2025 Jan 21;14:1519737. doi: 10.3389/fcimb.2024.1519737. eCollection 2024.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
March 5, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 13, 2026
Study Record Updates
Last Update Posted (Actual)
March 17, 2026
Last Update Submitted That Met QC Criteria
March 14, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBMEPGEEPAABFIMRCIOPA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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