NCT07469436

Brief Summary

  1. 1.Detection of expression level of mexB efflux pump gene in multidrug resistant clinical isolates of Pseudomonas aeruginosa by real time PCR(QRT-PCR).
  2. 2.Phenotypic detection of efflux pump activity in multidrug resistant clinical isolates of Pseudomonas aeruginosa.
  3. 3.Phenotypic detection of biofilm formation and its degree (strong-moderate-weak) in multidrug resistant clinical isolates of Pseudomonas aeruginosa.
  4. 4.Relationship between expression level of mexB efflux pump gene and degree of biofilm formation in multidrug resistant clinical isolates of Pseudomonas aeruginosa.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Apr 2026

Status
not yet recruiting

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

Study Progress19%
Apr 2026Jan 2028

First Submitted

Initial submission to the registry

March 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 5, 2026

Last Update Submit

March 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Detection of mexB efflux pump gene expression level in multidrug resistant clinical isolates of Pseudomonas aeruginosa

    molecular detection of mexB efflux pump gene expression level by real time PCR (QRT-PCR)

    one year

Secondary Outcomes (2)

  • Detection of efflux pump activity in multidrug resistant clinical isolates of Pseudomonas aeruginosa

    one year

  • Detection of degree of biofilm formation (strong-moderate-weak) in multidrug resistant clinical isolates of Pseudomonas aeruginosa

    one year

Interventions

Clinical isolates of Pseudomonas aeruginosa will undergo RNA extraction followed by cDNA (complementary DNA) synthesis. Quantitative real-time PCR will be performed using specific primers for the mexB efflux pump gene, and SYBR Green will be used to quantify gene expression. Housekeeping genes (e.g., rpoD or 16S rRNA) will serve as internal controls. The procedure allows precise quantification of mexB expression levels in each isolate.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multidrug resistant clinical isolates of Pseudomonas aeruginosa.

You may qualify if:

  • Clinical isolates confirmed as Pseudomonas aeruginosa by microbiological testing.
  • Isolates collected from different clinical specimens (e.g., wound swabs, sputum, urine, blood, and catheters).

You may not qualify if:

  • Bacterial species other than Pseudomonas aeruginosa.
  • Repeated clinical isolates from the same patient.
  • Repeated clinical specimens from different sources of the same patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 35302222BACKGROUND
  • 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.

    PMID: 40599435BACKGROUND
  • 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.

    PMID: 35873152BACKGROUND
  • 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.

    PMID: 33531042BACKGROUND
  • 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.

    PMID: 31976811BACKGROUND
  • 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.

    PMID: 37271271BACKGROUND
  • 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.

    PMID: 38596384BACKGROUND
  • 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.

    PMID: 23380871BACKGROUND
  • 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.

    PMID: 39906216BACKGROUND

MeSH Terms

Interventions

Real-Time Polymerase Chain Reaction

Intervention Hierarchy (Ancestors)

Polymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TechniquesInvestigative Techniques

Study Officials

  • Assiut University

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 5, 2026

First Posted

March 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share