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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMenoufia University

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (≥18 years).

Undergoing lithotripsy (FURS, URS or PCNL) with DJ stent insertion.

Stone free status.

Planned stent indwelling time of 1 month.

Disqualifiers

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

Treatments tested in this trial

  • Linezolid (LZD)
  • N-Acetyl Cysteine (NAC)

Treatment groups

100 Participants
are divided into 4 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Menoufia Faculty of Medicine Status unavailable 32511, Shebin El-Kom, MenoufiaEgyptEgypt

Sponsors and collaborators