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NCT Number: NCT07301294

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Linezolid (LZD)

Drug

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

N-Acetyl Cysteine (NAC)

Drug

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

Primary outcomes

  1. Biofilm bacterial load

    Time frame: 1 month

    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.

Secondary outcomes

  1. Urinary tract infection rate

    Time frame: 1 month

    urinary tract infection, defined as presence of positive urine culture after double J stent insertion, expressed in numbers.

  2. Double J related symptoms

    Time frame: 1 month

    Double J related symptoms, defined as lower urinary tract symptoms that patient expeirence after double J stent insertion, measured using the ureteral stent symptom questionnaire (USSQ), expressed in numbers.

Study contacts

Contact information is provided by the study sponsor or research team.

Ammar Alorabi

CONTACT

[email protected]

+201067608011

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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