Antibiotics for Preventing Infections After Kidney Stone Treatment

(STENTABX Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Indwelling catheters, Pregnancy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single dose of the antibiotic Ciprofloxacin can prevent infections after removing a stent used in kidney stone treatment. Participants will receive either the antibiotic or no treatment to determine any difference in infection rates. Individuals who recently had a stent placed for kidney stone surgery might be suitable for this study. The goal is to determine if taking this antibiotic effectively prevents infections after the procedure. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially benefit 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. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that ciprofloxacin is generally safe for preventing infections after procedures like kidney stone treatment. One study found that a single dose of ciprofloxacin can lower the risk of infections, such as pyelonephritis, following the procedure. This indicates its effectiveness in preventing infections with just one dose.

While ciprofloxacin is effective, some individuals have reported mild side effects, including nausea, diarrhea, or dizziness. These side effects are rare and usually not serious. The FDA has approved ciprofloxacin for treating infections, which supports its safety for this use.

Overall, evidence indicates that ciprofloxacin is a safe choice for preventing infections in similar medical situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a single oral dose of ciprofloxacin to prevent infections after kidney stone treatment because it offers a streamlined approach compared to the standard of care, which often involves longer antibiotic courses. This method focuses on administering the antibiotic right at the time of cystoscopic stent removal, potentially reducing the overall antibiotic exposure and its associated side effects. Additionally, the convenience of a single dose could enhance patient compliance and reduce the risk of antibiotic resistance, which is a growing concern in healthcare.

What evidence suggests that Ciprofloxacin might be an effective treatment for preventing infections after kidney stone treatment?

Research has shown that ciprofloxacin helps prevent infections after kidney stone treatments. In this trial, participants in the antibiotic arm will receive ciprofloxacin as a prophylactic measure during cystoscopic stent removal. Studies have found that this antibiotic lowers the risk of urinary infections after surgery by reaching high blood levels, which inhibit bacterial growth. Ciprofloxacin is also effective in treating urinary tract infections. Compared to other antibiotics, it often proves more effective and safer. This evidence supports using ciprofloxacin to prevent infections during procedures like cystoscopy with stent removal. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had recent kidney stone treatment surgery and have a ureteral stent placed within the last two weeks. It includes all ethnicities, with an expected mix of 60% men and 40% women. Excluded are those with catheters, pregnant women, or patients performing clean intermittent catheterization.

Inclusion Criteria

People of all ethnic backgrounds can join the study, and the mix of ethnicities in the study will match the diversity of the areas where the study is taking place.

I have had surgery for kidney stones.

You need to meet certain health requirements to participate in the study. Please refer to the specific inclusion criteria for details.

Exclusion Criteria

Pregnancy

You have a catheter placed in your abdomen.

You have a tube in your urethra to help you pee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants undergo cystoscopic stent removal with or without a single dose of prophylactic antibiotic

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-procedure infectious complications

8 weeks

Phone call interview between 7-14 days post-operatively, 1 visit (in-person) at 8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ciprofloxacin
• trimethoprim/sulfamethoxazole

Trial Overview The study tests if taking a single dose of Ciprofloxacin (an antibiotic) can prevent infections when removing ureteral stents after kidney stone treatments. Participants will be randomly assigned to receive either the antibiotic or no intervention during stent removal.

How Is the Trial Designed?

Group I: Antibiotic Active Control 2 Interventions

Patients randomized to the intervention arm will be provided a single oral dose of prophylactic oral antibiotic at the time of cystoscopic stent removal

Group II: No Antibiotic Active Control 1 Intervention

Patients randomized to the non-intervention arm will not undergo prophylaxis at the time of cystoscopic stent removal

Ciprofloxacin is already approved in United States, European Union, Canada, Switzerland for the following indications:

Approved in United States as Cipro for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Approved in European Union as Ciprofloxacin for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Approved in Canada as Cipro for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Approved in Switzerland as Ciprofloxacin for:

• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Intra-abdominal infections
• Certain types of infectious diarrhea
• Typhoid fever

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Genesis HealthCare

Collaborator

Trials

2

Recruited

198,000+

Published Research Related to This Trial

Ciprofloxacin is an effective antibiotic for treating a variety of infections, including osteomyelitis, gonorrhea, and infections of the urinary and gastrointestinal tracts, with data from 2,018 patients showing its broad-spectrum activity against multiple bacteria.

In controlled trials, ciprofloxacin demonstrated comparable or superior safety and efficacy compared to other antibiotics like trimethoprim-sulfamethoxazole and ampicillin, with mild adverse reactions and rare emergence of resistance, making it a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and potential economic benefits of oral ciprofloxacin in the treatment of infections. Sanders, WE.[2019]

Ciprofloxacin is generally well tolerated with a low incidence of adverse events, while other fluoroquinolones like sparfloxacin and grepafloxacin have higher rates of serious side effects, including phototoxicity and gastrointestinal intolerance.

Fluoroquinolones can interact with other medications, particularly those metabolized by the liver, which can affect drug clearance; therefore, careful monitoring of drug interactions is essential when prescribing these antibiotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the new fluoroquinolones compared with ciprofloxacin. Ball, P.[2019]

Ciprofloxacin is highly effective against nearly all uropathogens causing bacterial urinary tract infections, with low rates of resistance development.

The drug can be administered twice daily and achieves effective concentrations in key areas like blood, urine, kidneys, and prostate, making it suitable even for patients with advanced renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ciprofloxacin in management of urinary tract infection. Tolkoff-Rubin, NE., Rubin, RH.[2019]

Citations

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

Antibiotic prophylaxis in stone surgery: a systematic review ... According to EAU guidelines, antibiotic prophylaxis is recommended to lower the risk of symptomatic urinary infections following URS (strength ...

2. withpower.com withpower.com/trial/phase-urinary-calculi-2016-ecadd

Antibiotics for Preventing Infections After Kidney Stone ... Ciprofloxacin is effective in treating urinary tract infections and preventing postoperative infections, as it achieves high concentrations in the blood and ...

3. 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% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02944825

Antibiotic Prophylaxis With Routine Ureteral Stent Removal Ciprofloxacin is currently indicated for the treatment of acute uncomplicated urinary tract infections. Patients with fluoroquinalone allergy will receive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3539373/

Comparison of Infection and Urosepsis Rates ... This study aimed at determining the choice and administration duration of ideal antibiotic prophylaxis before percutaneous nephrolithotomy (PNL) operation, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0302283825005068

A Multicenter Randomized Controlled Trial of Antimicrobial ... A single dose of ciprofloxacin reduced the risk of post-SWL pyelonephritis, with a modest absolute benefit. The patient importance of this ...

7. renalandurologynews.com renalandurologynews.com/news/shockwave-lithotripsy-kidney-stones-antibiotic-cuts-infection-risk/

Antibiotic Prophylaxis Cuts Infection Risk After Shockwave ... The trial results demonstrate that antibiotic prophylaxis with single-dose ciprofloxacin probably reduces postprocedural infections, including ...