NCT07301294

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Double J Stent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-12-24
• Last updated: 2025-12-24

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study