Double J StentPhase 4NCT07301294
Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy.
A Phase 4 study testing Linezolid (LZD) and N-Acetyl Cysteine (NAC) in people with Double J Stent, run by Menoufia University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Double J Stent
- What is being tested?
- Linezolid (LZD) and N-Acetyl Cysteine (NAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Menoufia Faculty of Medicine
Shebin El-Kom, Menoufia, 32511
Mohamed Aziz, +201023321949, Mohammed_aziz2006@yahoo.com
About this study
Official title: Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled 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.
- Conditions
- Double J Stent
- Being tested
- Linezolid (LZD), N-Acetyl Cysteine (NAC)
- Keywords
- DJ stent, Double J stent, ureteric stent, Biofilm, Mucolytic, Linezolid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients of this group will receive no medications |
| Antibiotic group | Active comparator | Patients of this group will receive Linezolid. Receives: Drug: Linezolid (LZD) |
| Mucolytic group | Active comparator | Patients of this group will receive N-Acetylcysteine. Receives: Drug: N-Acetyl Cysteine (NAC) |
| Combination group | Active comparator | Patients of this group will receive both Linezolid and N-Acetylcysteine. Receives: Drug: Linezolid (LZD); Drug: N-Acetyl Cysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
Urinary tract infection rate
urinary tract infection, defined as presence of positive urine culture after double J stent insertion, expressed in numbers.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Double J StentStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Fathi Mohamed AlOrabi, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301294
- Sponsor's protocol ID
- Biofilm of DJ stent
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07301294
- Acronym / sponsor ID
- Biofilm of DJ stent
- Conditions
- Double J Stent
- Keywords
- DJ stent, Double J stent, ureteric stent, Biofilm, Mucolytic, Linezolid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients of this group will receive no medications |
| Antibiotic group | Active comparator | Drug: Linezolid (LZD)Patients of this group will receive Linezolid. |
| Mucolytic group | Active comparator | Drug: N-Acetyl Cysteine (NAC)Patients of this group will receive N-Acetylcysteine. |
| Combination group | Active comparator | Drug: Linezolid (LZD), Drug: N-Acetyl Cysteine (NAC)Patients of this group will receive both Linezolid and N-Acetylcysteine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linezolid (LZD)Linezolid 600 mg, oral, twice daily, for 7 days. | Drug | Antibiotic group, Combination group |
| N-Acetyl Cysteine (NAC)N-Acetyl cysteine 600 mg, oral, once daily, for 30 days. | Drug | Combination group, Mucolytic group |
Primary outcome
Biofilm bacterial load
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.
2 secondary outcomes
Urinary tract infection rate
Time frame: 1 month
Double J related symptoms
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linezolid (LZD) and N-Acetyl Cysteine (NAC) in people with Double J Stent, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ammar Alorabi (+201067608011, ammar.alorabi95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm bacterial load (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.