Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Linezolid (LZD), N-Acetyl Cysteine (NAC).
- Who it may be relevant to
- Registry conditions: Double J Stent. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Biofilm bacterial load [Time frame: 1 month]
Secondary outcome measures (2)
- Urinary tract infection rate [Time frame: 1 month]
- Double J related symptoms [Time frame: 1 month]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Menoufia Faculty of Medicine — Shebin El-Kom
Identifiers
NCT: NCT07301294 · Biofilm of DJ stent