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

NCT ID: NCT07301294

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Double J Stent

Keywords

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DJ stent Double J stent ureteric stent Biofilm Mucolytic Linezolid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Patients of this group will receive no medications

Group Type NO_INTERVENTION

No interventions assigned to this group

Antibiotic group

Patients of this group will receive Linezolid.

Group Type ACTIVE_COMPARATOR

Linezolid (LZD)

Intervention Type DRUG

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

Mucolytic group

Patients of this group will receive N-Acetylcysteine.

Group Type ACTIVE_COMPARATOR

N-Acetyl Cysteine (NAC)

Intervention Type DRUG

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

Combination group

Patients of this group will receive both Linezolid and N-Acetylcysteine.

Group Type ACTIVE_COMPARATOR

Linezolid (LZD)

Intervention Type DRUG

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

N-Acetyl Cysteine (NAC)

Intervention Type DRUG

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

Interventions

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Linezolid (LZD)

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

Intervention Type DRUG

N-Acetyl Cysteine (NAC)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Ammar Fathi Mohamed AlOrabi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia Faculty of Medicine

Shebin El-Kom, Menoufia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Ammar Alorabi

Role: CONTACT

Phone: +201067608011

Email: [email protected]

Facility Contacts

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Mohamed Aziz

Role: primary

Other Identifiers

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Biofilm of DJ stent

Identifier Type: -

Identifier Source: org_study_id