Antibiotic Duration for Kidney Stone Surgery

Overseen By Thomas Chi, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antibiotics

Disqualifiers: Pregnancy, Active infection, Recent antibiotics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the optimal duration for taking antibiotics before kidney stone surgery in individuals at moderate to high risk of infection. It seeks to determine if a shorter antibiotic course (2 days) is as effective and safe as a longer course (7 days). Suitable participants may have conditions such as a catheter or stent, asymptomatic bacteriuria (bacteria in urine without symptoms), or use immunosuppressants (medication that lowers the body's infection-fighting ability). The trial will compare these two antibiotic durations to assess if the shorter option is equally effective. As an unphased trial, it provides patients the chance to contribute to research that could enhance treatment protocols for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have taken antibiotics not prescribed for the study within 7 days before surgery, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking antibiotics for a short time before kidney stone surgery can be as effective and safe as taking them for a longer duration. Recent studies found that using antibiotics for only 2 days before surgery does not increase the risk of infections compared to using them for 7 days. This indicates that shorter antibiotic use is generally well-tolerated and does not lead to more complications.

Additionally, using antibiotics before surgery is a common method to prevent infections and is considered safe. No major safety concerns have been reported with short-term antibiotic use in these cases. Overall, both short and long courses of antibiotics are safe for patients undergoing procedures like ureteroscopy, a type of kidney stone surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the duration of preoperative antibiotics can impact kidney stone surgery outcomes. The standard care often involves a set duration for antibiotics, but this trial is comparing a longer regimen of 7 days against a shorter one of just 2 days. By investigating these different durations, researchers hope to find out if shorter antibiotic courses can be just as effective, potentially reducing side effects and the risk of antibiotic resistance. This could lead to a more tailored approach, improving patient care and outcomes.

What evidence suggests that this trial's treatments could be effective for kidney stone surgery?

This trial will compare the effectiveness of different durations of preoperative antibiotics for kidney stone surgery. A previous study found that using antibiotics for a shorter time before surgery was just as effective in preventing infections as using them for a longer period. Research shows that taking antibiotics for only two days can significantly reduce the risk of urinary infections after surgery. Another report found that using antibiotics for seven days did not further lower infection rates in high-risk patients after surgery. These findings suggest that a short, two-day course of antibiotics likely suffices to prevent infections in patients undergoing ureteroscopy, a procedure to remove kidney stones. ^{1 3 4 5 6}

Who Is on the Research Team?

Thomas Chi, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney stones who are at moderate to high risk of infection and planning to undergo ureteroscopy. They may have a stent, nephrostomy tube, or use catheters like foley or suprapubic. People with asymptomatic bacteriuria, bowel interposition, or immunosuppression can join. Pregnant individuals, those with active infections or recent non-study antibiotics cannot participate.

Inclusion Criteria

I am on immunosuppressants, possibly for a transplant or chemotherapy.

asymptomatic bacteriuria

indwelling ureteral stent in place

Exclusion Criteria

I took antibiotics not given by this study within a week before surgery.

I do not have any current infections.

pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Antibiotic Treatment

Participants receive either a short course (2 days) or a long course (7 days) of preoperative antibiotics

2-7 days

1 visit (in-person)

Surgery

Participants undergo ureteroscopy for stone removal

1 day

1 visit (in-person)

Follow-up

Participants are monitored for infectious and non-infectious complications, as well as adverse reactions to antibiotics

30 days

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Duration of antibiotics

Trial Overview The study compares the effectiveness of taking antibiotics for two days versus seven days before ureteroscopy in preventing post-operative infections. It's a randomized controlled trial aiming to see if a shorter antibiotic course is just as good as a longer one for patients at higher risk of complications.

How Is the Trial Designed?

Group I: Short duration of preoperative antibiotics (2 days) Experimental Treatment 1 Intervention

Group II: Long duration of preoperative antibiotics (7 days) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11876188/

Antibiotic prophylaxis in stone surgery: a systematic review ... Enhanced prophylactic measures, including preoperative urine cultures and tailored antibiotics, significantly reduces postoperative infection ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666168323010820

Comparative Effectiveness Randomized Clinical Trial ... The intervention significantly reduced postsurgical urinary infection risk by 7.1% (–0.73%, 15%) compared with the standard of care in the mITT analysis (1.4% ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02384200

Study Details | NCT02384200 | A Randomized Trial of ... Antibiotics the day of surgery will be a dose of ampicillin IV (2 g) and gentamicin IV (5 mg/kg) within 60 minutes of surgery start time. Patients with ...

4. liebertpub.com liebertpub.com/doi/10.1089/end.2024.0487

Longer Preoperative Antibiotic Duration Prior to High-Risk ... In high-risk patients, the duration of preoperative antibiotics prior to ureteroscopy did not reduce postoperative infectious complication rates.

5. withpower.com withpower.com/trial/phase-kidney-calculi-2024-cad88

Antibiotic Duration for Kidney Stone Surgery Trial Overview The study compares the effectiveness of taking antibiotics for two days versus seven days before ureteroscopy in preventing post-operative ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06149455

Preoperative Prophylactic Antibiotic Duration in Moderate to ... Recent randomized trials have demonstrated that short courses of pre-operative antibiotics are no less protective than long courses in patients ...