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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if an antibiotic can prevent infections in patients having a ureteral stent removed. The antibiotic works by killing or stopping the growth of bacteria that could cause infections. It has been shown to be effective in preventing infections in various surgical and medical contexts, including urinary tract infections and transurethral surgeries.

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.

What data supports the effectiveness of the drug ciprofloxacin for preventing infections after kidney stone treatment?

Ciprofloxacin is effective in treating urinary tract infections and preventing postoperative infections, as it achieves high concentrations in the blood and urine, inhibiting a wide range of bacteria. Studies show it reduces postoperative complications in patients undergoing kidney stone surgery. ^{1 2 3 4 5}

Is ciprofloxacin generally safe for human use?

Ciprofloxacin is generally well tolerated in humans, with low incidence of adverse events, which are usually mild. Serious side effects are rare, but it can interact with other drugs and may cause issues like phototoxicity (sensitivity to light) and tendinitis (inflammation of tendons). ^{4 6 7 8 9}

How does the drug ciprofloxacin differ from other treatments for preventing infections after kidney stone treatment?

Ciprofloxacin is unique because it is a fluoroquinolone antibiotic that effectively prevents infections by maintaining high concentrations in the blood and urine, surpassing the minimal inhibitory concentration needed to combat most bacteria. It is particularly effective when used preoperatively and continued postoperatively, reducing the risk of postoperative complications significantly compared to controls. ^{1 2 5 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

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

Ciprofloxacin in management of urinary tract infection. [2019]

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

Comparison of infection and urosepsis rates of ciprofloxacin and ceftriaxone prophylaxis before percutaneous nephrolithotomy: a prospective and randomised study. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

[The efficacy and tolerance of Bay-o-9867 (ciprofloxacin) in the treatment of infections of the urinary tract and of the lower respiratory tract]. [2013]

4. Italy pubmed.ncbi.nlm.nih.gov

[In vitro antibacterial activity of ciprofloxacin against uropathogenic organisms]. [2020]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The prevention of infectious-inflammatory complications in the postoperative period in percutaneous surgical interventions in patients with urolithiasis]. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

Comparative in vitro activity of the two new 4-quinolones S-25930 and S-25932 against gram-positive bacteria isolated from cancer patients. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

A critical review of the fluoroquinolones: focus on respiratory infections. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Which antibiotic prophylaxis to use for urologic procedures in patients at risk for infective endocarditis: a report on two cases. [2019]

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

Suppression of renal scarring by prednisolone combined with ciprofloxacin in ascending pyelonephritis in rats. [2019]