What side effects are associated with this type of intervention?

Ciprofloxacin, a common antibiotic used in the treatment of infections associated with kidney stones, can cause side effects such as nausea, diarrhea, dizziness, headache, and in rare cases, tendonitis or tendon rupture. Other treatments for kidney stones include NSAIDs and acetaminophen for pain management, which can lead to gastrointestinal issues and potential renal adverse effects. Surgical interventions or lithotripsy carry risks of infection, bleeding, and pain.

What prior FDA approvals exist?

The FDA has approved various treatments for kidney stones, primarily focusing on pain management, stone dissolution, and prevention of recurrence. While Ciprofloxacin is an antibiotic used to prevent bacterial infections, particularly during procedures like ureteral stent removal, it is not specifically approved for treating kidney stones themselves. Instead, it is used prophylactically to prevent infections that can occur during or after such procedures. Other treatments for kidney stones include medications like alpha-blockers to facilitate stone passage and drugs like potassium citrate to prevent stone formation.

What other types of research exist?

Promising alternatives to Ciprofloxacin for kidney stone patients include: 1) Fosfomycin, which has shown efficacy against multi-drug resistant uropathogens and is well-tolerated. 2) Nitrofurantoin, particularly for uncomplicated UTIs, though its use in kidney stones may be limited by its lower tissue penetration. 3) Newer beta-lactam/beta-lactamase inhibitor combinations like ceftolozane/tazobactam, which are effective against resistant strains. 4) Eravacycline, a newer tetracycline derivative with broad-spectrum activity, including against resistant bacteria. These options should be discussed with a healthcare provider to determine the best choice based on individual patient factors and bacterial susceptibility.

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Antibiotic

Antibiotics for Preventing Infections After Kidney Stone Treatment (STENTABX Trial)

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients having undergone kidney stone treatment surgery (shockwave lithotripsy [SWL], ureteroscopy [URS], retrograde intrarenal surgery [RIRS], percutaneous nephrolithotomy [PNL])

Age: >=18 years of age

Must not have

Patients who perform clean intermittent catheterization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 40 Other Conditions

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from Ciprofloxacin may include nausea, diarrhea, dizziness, and allergic reactions. Not everyone will experience these side effects; some might not have any at all.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery for kidney stones.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use a catheter periodically to empty my bladder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-procedure Infectious Complication

Secondary study objectives

Patient Risk Factors Predisposing to Post-procedure Infectious Complications

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 40 Other Conditions

This treatment demonstrated efficacy for 40 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: AntibioticActive Control2 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 AntibioticActive Control1 Intervention

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ciprofloxacin, an antibiotic commonly used in the treatment of kidney stones, works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and transcription. This action prevents bacterial growth and replication, thereby reducing the risk of infection. For kidney stone patients, especially those undergoing procedures like ureteral stent removal, preventing infections is critical as it can significantly impact recovery and overall health outcomes.