Menoufia Faculty of Medicine
Shebin El-Kom, Menoufia, 32511, Egypt
NCT Number: NCT07301294
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Shebin El-Kom, Menoufia, 32511, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Linezolid 600 mg, oral, twice daily, for 7 days.
N-Acetyl cysteine 600 mg, oral, once daily, for 30 days.
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.
Time frame: 1 month
urinary tract infection, defined as presence of positive urine culture after double J stent insertion, expressed in numbers.
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.
Contact information is provided by the study sponsor or research team.
Menoufia University
Other
Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial
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