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

NCT07301294 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Biofilm of DJ stent
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DJ stent; Double J stent; ureteric stent; Biofilm; Mucolytic; Linezolid

Outcome Measures

Primary Outcomes (1)

• Biofilm bacterial load

  Biofilm bacterial load, defined as the quantity of bacteria within a biofilm, measured by culture of a swab taken off Double J stent after removal and expressed in numbers.

  1 month

Secondary Outcomes (2)

• Urinary tract infection rate

  1 month

• Double J related symptoms

  1 month

Study Arms (4)

Control group

NO INTERVENTION

Patients of this group will receive no medications

Antibiotic group

ACTIVE COMPARATOR

Patients of this group will receive Linezolid.

Drug: Linezolid (LZD)

Mucolytic group

ACTIVE COMPARATOR

Patients of this group will receive N-Acetylcysteine.

Drug: N-Acetyl Cysteine (NAC)

Combination group

ACTIVE COMPARATOR

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

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

Interventions

Linezolid (LZD) DRUG

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

Antibiotic group; Combination group

N-Acetyl Cysteine (NAC) DRUG

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

Combination group; Mucolytic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, 32511, Egypt

Location

MeSH Terms

Interventions

Linezolid; Acetylcysteine

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Ammar Alorabi

CONTACT

+201067608011; ammar.alorabi95@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

EG (1)