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

Menoufia University

Status and phase: Not yet enrolling; Phase 4

Conditions: Double J Stent

Treatments: Drug: N-Acetyl Cysteine (NAC); Drug: Linezolid (LZD)

Study type: Interventional

Funder types: Other

Identifiers

NCT07301294

Biofilm of DJ stent

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adult patients (≥18 years).
• Undergoing lithotripsy (FURS, URS or PCNL) with DJ stent insertion.
• Stone free status.
• Planned stent indwelling time of 1 month.
• Negative preoperative urine culture.

Exclusion Criteria

• Known allergy or contraindication to linezolid or the selected mucolytic agent.
• Chronic kidney disease.
• Immunocompromised patients (e.g., chemotherapy, long-term steroid use).
• Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Control group

No Intervention group

Description:

Patients of this group will receive no medications

Antibiotic group

Active Comparator group

Description:

Patients of this group will receive Linezolid.

Treatment:

Drug: Linezolid (LZD)

Mucolytic group

Active Comparator group

Description:

Patients of this group will receive N-Acetylcysteine.

Treatment:

Drug: N-Acetyl Cysteine (NAC)

Combination group

Active Comparator group

Description:

Patients of this group will receive both Linezolid and N-Acetylcysteine.

Treatment:

Drug: Linezolid (LZD)

Drug: N-Acetyl Cysteine (NAC)