Infections, Urinary TractNCT06149455
Preoperative Prophylactic Antibiotic Duration in Moderate to High Risk Ureteroscopy
A study testing Duration of antibiotics in people with Infections, Urinary Tract and Nephrolithiasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Urinary Tract, Nephrolithiasis
- What is being tested?
- Duration of antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age (greater than or equal to 18 years)
- indwelling ureteral stent in place
- nephrostomy tube in place
- indwelling foley catheter, suprapubic catheter or clean intermittent catheterization
- asymptomatic bacteriuria
- bowel interposition (such as ileal conduit, neobladder)
- immunosuppression (such as for transplant recipients, active chemotherapy use)
Who cannot join
- pregnancy
- active infection
- received antibiotics within 7 days preceding surgery that were not prescribed for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
Thomas Chi, M.D., 415-353-2480, tom.chi@ucsf.edu
Victoria Hogue, M.A., Victoria.Hogue@ucsf.edu
About this study
Official title: A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Ureteroscopy in Moderate to High Infectious Risk Population
The goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. The main questions it aims to answer are:
- Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days)
- Identify secondary predictors of post-operative infectious complications
Read the detailed description
Post-operative infectious complications including urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), and sepsis are uncommon but potentially devastating complications after ureteroscopy. The clinical guidance from the American Urologic Association (AUA) and the European Association of Urology (EAU) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. As a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. This is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (MDR) organisms but are also more susceptible to deleterious outcomes due to their frailty. Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (PCNL) for stone removal. Ureteroscopy is the most commonly performed stone surgery worldwide. Establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. The goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms.
- Conditions
- Infections, Urinary Tract, Nephrolithiasis
- Being tested
- Duration of antibiotics
- Medical subject headings
- Urinary Tract Infections, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duration of antibioticsOther
Patients will be randomized to a short (2 days) or long (7 days) of pre-operative antibiotics, the choice of agent will be dependent upon bacterial sensitivities if available which is standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Short duration of preoperative antibiotics (2 days) | Experimental | Not described Receives: Other: Duration of antibiotics |
| Long duration of preoperative antibiotics (7 days) | Active comparator | Not described Receives: Other: Duration of antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
infectious complication rate
any occurrence of urinary tract infection, pyelonephritis, systemic inflammatory response syndrome or sepsis
Measured: 30 days after surgery
Secondary outcomes (3)
Non-infectious complications including readmission
Any other complications after the surgical procedure such as pain, readmission, urinary retention, etc
Measured: 30 days after surgery
Adverse reaction to antibiotic regimen
Any adverse reaction to antibiotic regimen
Measured: 2-7 days prior to surgery (depending on which arm the patient was randomized to)
Identification of secondary markers of post-operative sepsis
Markers of infection will be drawn preoperatively including erythrocyte sedimentation rate, c-reactive protein test, intra-operative renal pelvis pressure
Measured: Obtained during the peri-operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Urinary TractStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Chi, MD, MBA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149455
- Sponsor's protocol ID
- 22-37824
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics for Ureteroscopy in Moderate to High Infectious Risk Population
- ClinicalTrials.gov ID
- NCT06149455
- Acronym / sponsor ID
- 22-37824
- Conditions
- Infections, Urinary Tract, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 29 Nov 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 goal of this non-inferiority randomized controlled trial: is to test the hypothesis that the that there is no additional benefit from a longer course (7 days) versus a shorter course (2 days) of pre-operative antibiotics in patients with moderate to high risk of infection undergoing ureteroscopy. The main questions it aims to answer are:
- Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days)
- Identify secondary predictors of post-operative infectious complications
Detailed description
Post-operative infectious complications including urinary tract infection (UTI), systemic inflammatory response syndrome (SIRS), and sepsis are uncommon but potentially devastating complications after ureteroscopy. The clinical guidance from the American Urologic Association (AUA) and the European Association of Urology (EAU) is to provide treatment for symptomatic urinary tract infections however the management for asymptomatic patients with positive cultures or those patients who are otherwise at high risk of urinary tract colonization is unclear. As a result, there is significant practice variation in pre-operative prophylactic antibiotic prescription, even amongst fellowship trained endourologists, with some providers prescribing over ten days of pre-operative antibiotics while others offer none. This is a critical gap in our understanding of pre-operative prophylactic antibiotic utilization in a population of patients not only at higher risk of harboring multi-drug resistant (MDR) organisms but are also more susceptible to deleterious outcomes due to their frailty. Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients undergoing percutaneous nephrolithotomy (PCNL) for stone removal. Ureteroscopy is the most commonly performed stone surgery worldwide. Establishing an evidence-based approach for antibiotic prophylaxis in the ureteroscopic surgical patient population will be impactful for a large number of patients. The goal of this study is to implement a well-designed randomized clinical trial to establish the standardized antibiotic protocol necessary to minimize unnecessary antibiotic use which may otherwise lead to adverse reactions and proliferation of multi-drug resistant organisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short duration of preoperative antibiotics (2 days) | Experimental | Other: Duration of antibiotics |
| Long duration of preoperative antibiotics (7 days) | Active comparator | Other: Duration of antibiotics |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age (greater than or equal to 18 years)
- indwelling ureteral stent in place
- nephrostomy tube in place
- indwelling foley catheter, suprapubic catheter or clean intermittent catheterization
- asymptomatic bacteriuria
Key exclusion criteria (3 listed)
- pregnancy
- active infection
- received antibiotics within 7 days preceding surgery that were not prescribed for the study
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 |
|---|---|---|
| Duration of antibioticsPatients will be randomized to a short (2 days) or long (7 days) of pre-operative antibiotics, the choice of agent will be dependent upon bacterial sensitivities if available which is standard of care. | Other | Long duration of preoperative antibiotics (7 days), Short duration of preoperative antibiotics (2 days) |
Primary outcome
infectious complication rate
Time frame: 30 days after surgery
any occurrence of urinary tract infection, pyelonephritis, systemic inflammatory response syndrome or sepsis
3 secondary outcomes
Non-infectious complications including readmission
Time frame: 30 days after surgery
Adverse reaction to antibiotic regimen
Time frame: 2-7 days prior to surgery (depending on which arm the patient was randomized to)
Identification of secondary markers of post-operative sepsis
Time frame: Obtained during the peri-operative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: No. We have no plans to make individual participant data available to other researchers.
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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.
Thomas Chi, MD, MBA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duration of antibiotics in people with Infections, Urinary Tract and Nephrolithiasis, run by University of California, San Francisco 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Chi, MD, MBA (415-353-2200, tom.chi@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infectious complication rate (time frame: 30 days after 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 15 Dec 2023.