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Urinary Tract Infections (UTIs)NCT07482553

Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli

An observational study of Urinary Tract Infections (UTIs) and Catheter-Associated Urinary Tract Infections (CAUTIs), run by Assiut University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

1. Isolation of uropathogenic Escherichia coli (UPEC) and determination of their Antimicrobial sensitivity Patterns. 2. Evaluation of biofilm-forming capacity of UPEC isolates. 3. Assessment of the antibiofilm efficacy of chitosan nanoparticles alone and in combination with ciprofloxacin against UPEC isolates. 4. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
chitosan nanoparticles
How many people
60 participants
Where
1 siteEgypt
Study dates
1 May 2026to Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yasmin G Shazly, Demonstrator contact

+20 109 017 7354

yasmin.g.shazly@aun.edu.eg

Egypt1 site
  • Faculty of Medicine, Assiut University, Microbiology and Immunity department

    Asyut, Assiut Governorate

Other trials in Egypt

About this study

Official title: Evaluation of the Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli Isolated From Assiut University Hospitals

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

Urinary tract infections (UTIs) remain among the most prevalent bacterial infections globally, causing substantial healthcare burden, with uropathogenic Escherichia coli (UPEC) responsible for the majority of cases in both community and hospital settings. Catheter-associated urinary tract infections (CAUTIs) represent a major proportion of healthcare-associated infections due to bacterial adhesion and biofilm formation on indwelling urinary catheters. Biofilm formation enables microorganisms to attach to abiotic surfaces and produce an extracellular polymeric matrix that enhances bacterial survival under adverse environmental conditions.

Biofilm-associated bacteria exhibit increased resistance to host immune responses and antimicrobial agents, contributing to chronic and recurrent infections. Cells embedded within biofilms may demonstrate markedly elevated antibiotic tolerance compared with planktonic bacteria, limiting therapeutic success. Although systemic antibiotics remain the mainstay of treatment, rising antimicrobial resistance among biofilm forming UPEC strains highlights the need for alternative antibiofilm strategies.

Chitosan, a naturally derived biopolymer, has attracted attention due to its biocompatibility, biodegradability, and intrinsic antimicrobial properties. Chitosan disrupts bacterial membranes and inhibits biofilm matrix formation and surface adhesion. Emerging evidence indicates that chitosan can downregulate biofilm-related gene expression involved in adhesion and extracellular polysaccharide synthesis. Furthermore, nanoparticle formulation enhances chitosan penetration into biofilms and improves antimicrobial efficiency compared with bulk polymer forms. Moreover, chitosan nanoparticles may enhance antibiotic diffusion and demonstrate synergistic antibiofilm activity when combined with ciprofloxacin.

Ciprofloxacin, a fluoroquinolone antibiotic widely used in UTIs, has demonstrated partial inhibition of biofilm formation through interference with bacterial DNA replication, initial bacterial adhesion to surfaces, reduction of expression of biofilm-related genes, quorum-sensing activity and decreases production of extracellular polymeric substances (EPS); however, its efficacy is reduced against mature biofilms. Consequently, chitosan nanoparticles may demonstrate enhanced antibiofilm activity when combined with ciprofloxacin.

Despite promising findings, limited studies have evaluated chitosan nanoparticle coatings on clinically relevant catheter surfaces against UPEC isolates. Therefore, investigating this strategy may offer an effective preventive approach for CAUTIs and support improved infection control practices.

Being tested
chitosan nanoparticles
Keywords
Uropathogenic Escherichia coli (UPEC), Biofilm, Chitosan Nanoparticles, Ciprofloxacin, Catheter-Associated Urinary Tract Infection (CAUTI), Antibiofilm Activity, Urinary Catheter Biofilm, quantitative real-time polymerase chain reaction (qRT-PCR) gene expression
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chitosan nanoparticlesOther

    Also called CS-NPs

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours after treatment of bacterial cultures in vitro.

Secondary outcomes (3)
  1. Minimum Inhibitory Concentration (MIC) of chitosan nanoparticles and ciprofloxacin against UPEC isolates

    The MIC of chitosan nanoparticles and ciprofloxacin will be determined for strong biofilm-forming UPEC isolates using the broth microdilution method in sterile 96-well microtiter plates. Two-fold serial dilutions of each agent will be prepared in tryptic soy broth (TSB) and inoculated with standardized bacterial suspensions. The MIC will be recorded as the lowest concentration showing no visible bacterial growth compared with growth controls.

    Measured: 18-24 hours after inoculation

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

    This outcome evaluates the ability of chitosan nanoparticle coating to inhibit biofilm formation on 1-cm urinary catheter segments. Coated segments will be incubated with standardized UPEC suspensions for 18 hours. Biofilm biomass will be quantified by crystal violet staining, solubilization with ethanol, and optical density (OD) measurement at 595 nm. Percentage of biofilm inhibition will be calculated as [(ODcontrol - ODTreated)/ODcontrol] × 100. Experiments will be performed in duplicate.

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

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

    The secondary outcome is the change in expression levels of fimH and luxS genes in strong biofilm-forming UPEC isolates following treatment with chitosan nanoparticles. Ribonucleic acid (RNA) will be extracted, converted to complementary DNA (cDNA), and analyzed using SYBR Green quantitative real-time polymerase chain reaction (qRT-PCR). Gene expression will be normalized to the housekeeping gene rpoD and calculated using the 2-ΔΔCt method. Each reaction will be performed in triplicate, and mean values will be reported.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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 only
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07482553
Sponsor's protocol ID
not assigned yet
Status last verified
Mar 2026
First submitted
15 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oliveira MCF, Canellas ALB, Berbert LC, Cardoso AM, Silva VA, Garutti SST, Rangel DHF, Dias RCS, Perini JA, Souza CRVM, Chagas TPG, Laport MS, Pellegrino FLPC. Assessment of Antimicrobial Resistance and Virulence of Biofilm-Forming Uropathogenic Escherichia coli from Rio de Janeiro. Antibiotics (Basel). 2025 Aug 29;14(9):869. doi: 10.3390/antibiotics14090869.

    PubMed 41009848
  • Wiegand I, Hilpert K, Hancock RE. Agar and broth dilution methods to determine the minimal inhibitory concentration (MIC) of antimicrobial substances. Nat Protoc. 2008;3(2):163-75. doi: 10.1038/nprot.2007.521.

    PubMed 18274517
  • 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.

  • 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 Oct 26;7(4):415-430. doi: 10.3934/microbiol.2021025. eCollection 2021.

    PubMed 35071940
  • 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 Jan 12;14:79-87. doi: 10.2147/IDR.S282386. eCollection 2021.

    PubMed 33469322
  • Hooton TM, Gupta K. Urinary tract infections and asymptomatic bacteriuria in adults. N Engl J Med. 2021;384(11):1028-37.

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

  • Yan J, Bassler BL. Surviving as a Community: Antibiotic Tolerance and Persistence in Bacterial Biofilms. Cell Host Microbe. 2019 Jul 10;26(1):15-21. doi: 10.1016/j.chom.2019.06.002.

    PubMed 31295420
  • Flemming HC, Wuertz S. Bacteria and archaea on Earth and their abundance in biofilms. Nat Rev Microbiol. 2019 Apr;17(4):247-260. doi: 10.1038/s41579-019-0158-9.

    PubMed 30760902
  • Klein RD, Hultgren SJ. Urinary tract infections: microbial pathogenesis, host-pathogen interactions and new treatment strategies. Nat Rev Microbiol. 2020 Apr;18(4):211-226. doi: 10.1038/s41579-020-0324-0. Epub 2020 Feb 18.

    PubMed 32071440
  • Sahariah P, Masson M. Antimicrobial chitosan nanoparticles: applications and mechanisms. Biomacromolecules. 2021;22(2):363-380.

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Tract Infections (UTIs) and Catheter-Associated Urinary Tract Infections (CAUTIs), run by Assiut 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yasmin G Shazly, Demonstrator (+20 109 017 7354, yasmin.g.shazly@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of biofilm inhibition of UPEC isolates by chitosan nanoparticles alone and in combination with ciprofloxacin (time frame: 24 hours after treatment of bacterial cultures in vitro.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07482553, which also lists 11 linked publications.

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 27 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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