Antibiotics for Preventing Infections After Kidney Stone Treatment

(STENTABX Trial)

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Approved in 4 Jurisdictions

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.

Research Team

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.

Treatment Details

Interventions

• Ciprofloxacin (Antibiotic)
• trimethoprim/sulfamethoxazole (Antibiotic)

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 Canada, Switzerland for the following indications:

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+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University

Genesis HealthCare

Collaborator

Trials

2

Recruited

198,000+