NCT07482553

Brief Summary

  1. 1.Isolation of uropathogenic Escherichia coli (UPEC) and determination of their Antimicrobial sensitivity Patterns.
  2. 2.Evaluation of biofilm-forming capacity of UPEC isolates.
  3. 3.Assessment of the antibiofilm efficacy of chitosan nanoparticles alone and in combination with ciprofloxacin against UPEC isolates.
  4. 4.Examination of the effectiveness of chitosan nanoparticle coating in preventing biofilm formation by UPEC on urinary catheter surfaces.
  5. 5.Evaluation of the impact of chitosan nanoparticles on the expression levels of biofilm associated genes in UPEC.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

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 Progress24%
May 2026Jun 2027

First Submitted

Initial submission to the registry

March 15, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 15, 2026

Last Update Submit

March 23, 2026

Conditions

Urinary Tract Infections (UTIs)Catheter-Associated Urinary Tract Infections (CAUTIs)Biofilm Formation by Uropathogenic Escherichia Coli (UPEC)

Keywords

Uropathogenic Escherichia coli (UPEC)BiofilmChitosan NanoparticlesCiprofloxacinCatheter-Associated Urinary Tract Infection (CAUTI)Antibiofilm ActivityUrinary Catheter Biofilmquantitative real-time polymerase chain reaction (qRT-PCR) gene expression

Outcome Measures

Primary Outcomes (1)

  • Percentage of biofilm inhibition of UPEC isolates by chitosan nanoparticles alone and in combination with ciprofloxacin

    The primary outcome is the reduction in biofilm formation of strong biofilm-producing uropathogenic Escherichia coli (UPEC) isolates after treatment with sub-inhibitory concentrations of chitosan nanoparticles alone or combined with ciprofloxacin. Biofilm biomass will be quantified using the crystal violet microtiter plate assay, and the percentage of inhibition will be calculated using optical density (OD) values according to the following formula: \[(ODcontrol - ODTreated)/ODcontrol\] × 100. Each experiment will be performed in triplicate and the mean values will be reported.

    24 hours after treatment of bacterial cultures in vitro.

Secondary Outcomes (3)

  • Minimum Inhibitory Concentration (MIC) of chitosan nanoparticles and ciprofloxacin against UPEC isolates

    18-24 hours after inoculation

  • Effectiveness of chitosan nanoparticle coating in preventing UPEC biofilm formation on urinary catheter segments

    18-24 hours after bacterial incubation on coated catheter segments.

  • Relative gene expression of biofilm-associated genes (fimH and luxS) in UPEC isolates after chitosan nanoparticle treatment

    Immediately after 24-hour treatment of bacterial cultures in vitro.

Interventions

chitosan nanoparticlesOTHER

Chitosan nanoparticles will be applied to strong biofilm-forming UPEC isolates in vitro to evaluate their antibiofilm activity. Treatments include: * Chitosan nanoparticles alone at sub-inhibitory concentrations * Ciprofloxacin alone at sub-inhibitory concentrations * Combination of chitosan nanoparticles and ciprofloxacin Biofilm formation will be quantified using crystal violet staining in 96-well microtiter plates. The intervention also includes coating of urinary catheter segments with chitosan nanoparticles to assess biofilm inhibition.

Also known as: CS-NPs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include UTI patients attending Assiut University Hospitals. Urine samples will be collected aseptically for isolation of uropathogenic E. coli. Only patients meeting inclusion criteria and providing consent will be included.

You may qualify if:

  • \. Patients (inpatients or outpatients) clinically diagnosed with urinary tract infection (UTI).
  • \. Presence of significant bacteriuria in urine culture (≥10⁵ colony-forming units per milliliter (CFU/mL) for midstream urine, or as clinically indicated).
  • \. Isolation of Escherichia coli as the sole or predominant pathogen from urine culture.
  • \. Patients of any age and both sexes. 5. Patients who have not received antibiotic therapy within the previous 48-72 hours.

You may not qualify if:

  • \. Patients who received systemic antibiotic therapy within the previous 48-72 hours prior to urine sample collection.
  • \. Urine cultures showing insignificant bacteriuria (\<10⁵ CFU/mL for midstream urine, unless clinically justified).
  • \. Polymicrobial growth in urine culture (mixed bacterial growth suggestive of contamination).
  • \. Isolation of organisms other than Escherichia coli. 5. Improperly collected, leaking, or contaminated urine samples. 6. Patients unwilling to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University, Microbiology and Immunity department

Asyut, Assiut Governorate, Egypt

Location

Related Publications (11)

  • Oliveira MCF, Canellas ALB, Berbert LC, Cardoso AM, Silva VA, Garutti SST, et al. Assessment of antimicrobial resistance and virulence of biofilm-forming uropathogenic Escherichia coli from Rio de Janeiro. Antibiotics (Basel). 2025;14(9):869.

    BACKGROUND

  • Wiegand I, Hilpert K, Hancock REW. Agar and broth dilution methods to determine the minimal inhibitory concentration (MIC) of antimicrobial substances. Nat Protoc. 2020;15(6):1957-1978.

    BACKGROUND

  • Obaid NA, Alzahrani AM, Alaryni BA, Almegrin FF, Alsubhi RS, Alzahrani RS, et al. Effectiveness of chitosan coating catheter in preventing catheter-associated urinary tract infection (CAUTI). J Pharm Res Int. 2022;34(19A):6-19.

    BACKGROUND

  • Fattah RAFA, Fathy FEZY, Mohamed TAH, Elsayed MS. Effect of chitosan nanoparticles on quorum sensing-controlled virulence factors and expression of LasI and RhlI genes among Pseudomonas aeruginosa clinical isolates. AIMS Microbiol. 2021;7(4):415-430.

    BACKGROUND

  • Yao H, Liu J, Jiang X, Chen F, Lu X, Zhang J. Analysis of the clinical effect of combined drug susceptibility to guide medication for carbapenem-resistant Klebsiella pneumoniae patients based on the Kirby-Bauer disk diffusion method. Infect Drug Resist 2021; 14: 79-87.

    BACKGROUND

  • Hooton TM, Gupta K. Urinary tract infections and asymptomatic bacteriuria in adults. N Engl J Med. 2021;384(11):1028-37.

    BACKGROUND

  • Singh S, et al. Nanotechnology-based coatings for prevention of catheter-associated infections. Nanomedicine. 2024; 52:102640.

    BACKGROUND

  • Yan J, Bassler BL. Surviving as a community: biofilm tolerance mechanisms. Cell Host Microbe. 2022;30(1):15-26.

    BACKGROUND

  • Flemming HC, Wuertz S. Bacteria and archaea on Earth and their biofilms. Nat Rev Microbiol. 2021;19(4):247-60.

    BACKGROUND

  • Klein RD, Hultgren SJ. Urinary tract infections: microbial pathogenesis and host response. Nat Rev Microbiol. 2020;18(4):211-26.

    BACKGROUND

  • Sahariah P, Masson M. Antimicrobial chitosan nanoparticles: applications and mechanisms. Biomacromolecules. 2021;22(2):363-380.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine samples collected from patients with urinary tract infections will be used for isolation of uropathogenic Escherichia coli (UPEC). The isolated bacterial strains will be retained for laboratory analysis including antimicrobial susceptibility testing, biofilm formation assays, and molecular analysis of biofilm-related genes (fimH and luxS) using quantitative real-time polymerase chain reaction (qRT-PCR). Bacterial isolates may be stored as glycerol stocks at -80 °C for further experimental studies.

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Yasmin G Shazly, Demonstrator

CONTACT

+20 109 017 7354yasmin.g.shazly@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

EG(1)