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

72 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug used for antibiotic duration in kidney stone surgery?

Research suggests that using antibiotics, particularly fluoroquinolones, can effectively prevent infections after kidney stone surgery. This is especially important for patients with infection stones or those at higher risk of infection, such as those with diabetes or anatomical anomalies. ^{1 2 3 4 5}

Is it safe to use antibiotics for kidney stone surgery?

Research shows that using antibiotics before kidney stone surgery is generally safe and can help prevent infections. However, the exact duration of antibiotic use varies, and it's important to follow the specific recommendations for each type of surgery. ^{2 6 7 8 9}

How does the antibiotic duration treatment for kidney stone surgery differ from other treatments?

This treatment focuses on determining the optimal duration of antibiotic use to prevent infections after kidney stone surgery, which is unique because there is no consensus on how long antibiotics should be used in this context. Unlike standard treatments, this approach aims to balance effective infection prevention with minimizing unnecessary antibiotic exposure. ^{2 8 10 11 12}

What is the purpose of this trial?

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: 1. Determine the safety and efficacy of a short course (2 days) as compared to a long course (7 days) 2. Identify secondary predictors of post-operative infectious complications

Research Team

Thomas Chi, M.D.

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Comparative study of the bacterial distribution and antimicrobial susceptibility of uropathogens in older and younger patients with urinary stones. [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Infections and urolithiasis: current clinical evidence in prophylaxis and antibiotic therapy. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Obstructing Ureteral Calculi and Presumed Infection: Impact of Antimicrobial Duration and Time From Decompression to Stone Treatment in Developing Urosepsis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative antibiotic prophylaxis for stone therapy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term Recurrence Rates in Uric Acid Stone Formers With or Without Medical Management. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Preoperative Prophylactic Antibiotics Prior to Percutaneous Nephrolithotomy in a Low Infectious Risk Population: A Report from the EDGE Consortium. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative infection rates in patients with a negative baseline urine culture undergoing ureteroscopic stone removal: a matched case-control analysis on antibiotic prophylaxis from the CROES URS global study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Are prophylactic antibiotics necessary in patients with preoperative sterile urine undergoing ureterorenoscopic lithotripsy? [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Emergency treatment of symptomatic ureteral calculi: predictors of prolonged hospital stay. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Renal stones and urinary infection: a study of antibiotic treatment. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Netilmicin sulfate prophylaxis in the surgical treatment of renal stones. [2013]

12. France pubmed.ncbi.nlm.nih.gov

[Comparative study of cefoperazone and cotrimoxazole in kidney stone surgery via percutaneous approach]. [2015]