Urinary Tract InfectionsPhase 2NCT06007352
Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
A Phase 2 study testing Gentamicin in people with Urinary Tract Infections and Sepsis, run by Yale University at 1 site in United States.
Trial summary
The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections, Sepsis
- What is being tested?
- Gentamicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis
- At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below:
- 3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy
- Prior infectious complication following ureteroscopy
Show all 11Show fewer
- Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection
- Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy
- Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Who cannot join
- Estimated Glomerular Filtration Rate less than 60 mL/min
- History of sensorineural hearing loss, vertigo, idiopathic dizziness
- Active pregnancy or currently lactating
- Known allergic reactions to components of gentamicin
- Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.
Read the detailed description
The primary objective of this study is to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day post-operative symptomatic urinary tract infections in patients at higher risk of urinary tract infection undergoing stone surgery for urolithiasis.
The secondary objectives of this study are to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS criteria, and overall post-operative oral/intravenous antibiotic administration.
In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40 μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg. For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal function, and gentamicin peak and trough levels are not routinely obtained.
- Conditions
- Urinary Tract Infections, Sepsis
- Being tested
- Gentamicin, Placebo
- Keywords
- UTI, Gentamicin, Ureteroscopy
- Medical subject headings
- Urinary Tract Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GentamicinDrug
Participants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy
PlaceboOther
3 L of NaCl irrigation typically used for ureteroscopy surgery
| Study group | Role | What they receive |
|---|---|---|
| Gentamicin-Based Irrigation | Experimental | This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy Receives: Drug: Gentamicin |
| 3 L NaCl Irrigation | Placebo comparator | This group will receive the typical NaCl irrigation used during ureteroscopy Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic urinary tract infection
Development of a symptomatic urinary tract infection after surgery
Measured: Within 30 days of surgery
Secondary outcomes (3)
Urosepsis
Development of urosepsis after URS based on SIRS criteria
Measured: Within 30 days of surgery
Re-admission to hospital
Re-admission to hospital after surgery for any reason
Measured: Within 30 days of surgery
Patient self-reported symptoms
Self-reported symptoms after the operation of the following: new hearing loss, vertigo and dizziness
Measured: within 30 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Yale 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- phase II, parallel randomized control trial with 1:1 allocation
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piruz Motamedinia, M.D., Principal investigator, Yale School of Medicine, Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007352
- Sponsor's protocol ID
- 2000035721
- Other IDs
- 000
- Status last verified
- Jan 2025
- First submitted
- 17 Aug 2023
- Last updated
- 16 Jan 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
- ClinicalTrials.gov ID
- NCT06007352
- Acronym / sponsor ID
- 2000035721
- Conditions
- Urinary Tract Infections, Sepsis
- Keywords
- UTI, Gentamicin, Ureteroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Aug 2023 (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.
The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.
Detailed description
The primary objective of this study is to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy decreases the rate of 30-day post-operative symptomatic urinary tract infections in patients at higher risk of urinary tract infection undergoing stone surgery for urolithiasis.
The secondary objectives of this study are to determine whether the utilization of gentamicin-based irrigation fluid during ureteroscopy affects the 30-day post-operative rates of patient-initiated telephone calls, readmission rates, urosepsis rates based on SIRS criteria, and overall post-operative oral/intravenous antibiotic administration.
In this prospective study, 120 mg of gentamicin prepared in 3 liters of normal saline will be used as irrigation during ureteroscopic surgery for urolithiasis. At this concentration, 40 μg/mL, the MBC would be achieved for pathogenic urogenital bacteria. Due to the concerns of nephrotoxicity and ototoxicity at higher doses of gentamicin, in the unlikely event of complete pyelo-venous backflow, the intravenous circulation of 120 mg of gentamicin would be less than the surgical prophylaxis intravenous dosing for patients weighing more than 60 kg. For the single intravenous dose for surgical prophylaxis, post-operative monitoring of renal function, and gentamicin peak and trough levels are not routinely obtained.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- phase II, parallel randomized control trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Gentamicin-Based Irrigation | Experimental | Drug: GentamicinThis group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy |
| 3 L NaCl Irrigation | Placebo comparator | Other: PlaceboThis group will receive the typical NaCl irrigation used during ureteroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis
- At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below:
- 3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy
Key exclusion criteria (5 listed)
- Estimated Glomerular Filtration Rate less than 60 mL/min
- History of sensorineural hearing loss, vertigo, idiopathic dizziness
- Active pregnancy or currently lactating
- Known allergic reactions to components of gentamicin
- Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis
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 |
|---|---|---|
| GentamicinParticipants will be given 120 mg of gentamicin infused in 3 L NaCl used in irrigation for ureteroscopy | Drug | Gentamicin-Based Irrigation |
| Placebo3 L of NaCl irrigation typically used for ureteroscopy surgery | Other | 3 L NaCl Irrigation |
Primary outcome
Symptomatic urinary tract infection
Time frame: Within 30 days of surgery
Development of a symptomatic urinary tract infection after surgery
3 secondary outcomes
Urosepsis
Time frame: Within 30 days of surgery
Re-admission to hospital
Time frame: Within 30 days of surgery
Patient self-reported symptoms
Time frame: within 30 days of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Piruz Motamedinia, M.D. principal investigator
Yale School of Medicine, Department of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gentamicin in people with Urinary Tract Infections and Sepsis, run by Yale University at 1 site in United States.
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 11 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Jan 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic urinary tract infection (time frame: Within 30 days of surgery). 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 16 Jan 2025.