Health TrialsbyHealthPanel

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

ConditionDouble J Stent
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Antibiotic groupActive comparator 1 intervention
Group C: Mucolytic groupActive comparator 1 intervention
Group D: Combination groupActive comparator 2 interventions

Trial outcomes

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.

Time frame
1 month

Secondary outcomes

1

Urinary tract infection rate

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

Time frame
1 month
2

Double J related symptoms

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.

Time frame
1 month

Other outcomes

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 contacts

Click on the lead sponsor to view all of their trials.

Menoufia University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: