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Starting soon Observational

Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli

NCT07482553 · tracked via the Priya Life Science Egypt tracker
Phase
Observational
Started
2026-05-01
Last updated
2026-03-27

Condition(s) studied

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

Investigational drug(s) / intervention(s)

chitosan nanoparticles

chitosan nanoparticles: 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.

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Percentage of biofilm inhibition of UPEC isolates by chitosan nanoparticles alone and in combination with ciprofloxacin — 24 hours after treatment of bacterial cultures in vitro.
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine, Assiut University, Microbiology and Immunity department Asyut Assiut Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07482553 on ClinicalTrials.gov ↗ ← All trials in Egypt