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NOT YET RECRUITING
NCT07301294
PHASE4

Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.

Sponsor: Menoufia University

View on ClinicalTrials.gov

Summary

Indwelling Double J (DJ) ureteral stents are commonly used following lithotripsy to ensure adequate urinary drainage and prevent obstruction. However, stent-related biofilm formation remains a significant clinical problem, contributing to infection, encrustation, patient discomfort, and stent failure. Biofilms consist of microbial communities embedded within an extracellular polymeric substance (EPS), which protects microorganisms from host defenses and antimicrobial agents. Antibiotic therapy alone may be insufficient to eradicate established biofilms due to poor penetration into the EPS matrix. Linezolid is a potent antibiotic with activity against gram-positive organisms commonly implicated in urinary tract colonization and penetrate and effectively act against bacterial biofilms. Mucolytic agents, by disrupting the biofilm matrix, may enhance antimicrobial penetration and reduce biofilm burden. The combination of an antibiotic with a mucolytic agent may therefore provide superior biofilm reduction compared to either approach alone or no treatment.

Official title: Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-01-01

Completion Date

2026-07-01

Last Updated

2025-12-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

Linezolid (LZD)

Linezolid 600 mg, oral, twice daily, for 7 days.

DRUG

N-Acetyl Cysteine (NAC)

N-Acetyl cysteine 600 mg, oral, once daily, for 30 days.

Locations (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, Egypt