Antibiotic Prophylaxis for Kidney Stones

(APPEAL Trial)

No longer recruiting at 11 trial locations

Overseen By Kari AO Tikkinen, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Clinical Urology and Epidemiology Working Group

Must not be taking: Antibiotics

Disqualifiers: Positive urine culture, Struvite stone, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single dose of the antibiotic ciprofloxacin before shockwave lithotripsy (SWL) for kidney stones can prevent infections. Participants will receive either ciprofloxacin or a placebo to compare effects. It is ideal for adults scheduled for SWL who do not have a current urinary tract infection or other specific medical conditions. The goal is to enhance patient care by understanding antibiotics' role in reducing complications during kidney stone treatment. As a Phase 4 trial, this research examines an FDA-approved treatment to explore its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking antibiotics for a urinary tract infection or other reasons.

What is the safety track record for ciprofloxacin?

Studies have shown that ciprofloxacin is generally safe for many people, but it carries some risks. In a large study with over 800 participants, ciprofloxacin was used without major safety concerns. However, rare cases of kidney problems have occurred. For example, an elderly woman developed a kidney issue after taking ciprofloxacin.

Ciprofloxacin is not recommended for people with severe kidney disease, as it might worsen their condition. Despite these concerns, the antibiotic has effectively lowered the risk of infection after treatments like shockwave lithotripsy, which breaks up kidney stones. Overall, while ciprofloxacin is usually well-tolerated, discussing any personal health conditions with a doctor before using it is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using ciprofloxacin for kidney stones because it offers a new approach by acting as an antibiotic prophylaxis to prevent infections that can occur after shockwave lithotripsy, a common procedure to break down kidney stones. Unlike standard treatments that focus on pain management or stone removal, ciprofloxacin aims to reduce the risk of post-procedure infections with a single dose, which could simplify patient care and enhance recovery. By potentially offering protection against bacterial infections without the need for extended antibiotic courses, this approach could streamline treatment and minimize side effects associated with long-term antibiotic use.

What evidence suggests that this trial's treatments could be effective for kidney stones?

Research has shown that ciprofloxacin can reduce infections after surgery. In this trial, participants will receive either a single dose of ciprofloxacin or a placebo before undergoing shockwave lithotripsy for kidney stones. Studies have found that a single dose of ciprofloxacin before surgery can lower the risk of postoperative infections. One study showed ciprofloxacin reduced infections compared to not using it. Another trial confirmed ciprofloxacin's effectiveness in preventing infections, which is especially important for surgeries like kidney stone removal. Overall, the evidence supports ciprofloxacin as a useful preventive measure in these medical situations. ^{6 7 8 9 10}

Who Is on the Research Team?

Philippe D Violette, MD CM

Principal Investigator

McMaster University

Kari AO Tikkinen, MD PhD

Principal Investigator

University of Helsinki

Are You a Good Fit for This Trial?

This trial is for adults over 18 with kidney or ureter stones scheduled for shock wave lithotripsy (SWL). Participants must not have a specific type of stone called struvite, any urinary diversions, history of severe infection after SWL, allergies to the study antibiotic, or be on antibiotics for UTI. They also shouldn't have certain conditions that make joining the trial not in their best interest.

Exclusion Criteria

I use a catheter regularly for urination.

I have a urinary diversion in place.

In the opinion of the independent treating urologist, it is not in the patient's best interest to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ciprofloxacin or placebo prior to shock wave lithotripsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including urine culture and symptom questionnaires

2 weeks

1 visit (in-person or virtual), additional follow-up by mail

What Are the Treatments Tested in This Trial?

Interventions

• Ciprofloxacin
• Placebo

Trial Overview The study compares two treatments before SWL: one group receives a single dose of an antibiotic called Ciprofloxacin and the other gets a saline placebo. It's a double-blind RCT which means neither patients nor doctors know who's getting what treatment. The trial includes various international medical centers.

How Is the Trial Designed?

Group I: ciprofloxacin Experimental Treatment 1 Intervention

Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy

Group II: Placebo Placebo Group 1 Intervention

identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.

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?

Clinical Urology and Epidemiology Working Group

Lead Sponsor

Trials

4

Recruited

7,800+

Dr Cipto Mangunkusumo General Hospital

Collaborator

Trials

46

Recruited

12,100+

Hospital Sao Luiz

Collaborator

Trials

1

Recruited

1,700+

Tallaght University Hospital

Collaborator

Trials

10

Recruited

2,500+

St. Petersburg State Pavlov Medical University

Collaborator

Trials

59

Recruited

82,900+

Tabriz University of Medical Sciences

Collaborator

Trials

20

Recruited

10,800+

University Hospital, Basel, Switzerland

Collaborator

Trials

1,031

Recruited

2,503,000+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

King Abdulaziz University

Collaborator

Trials

77

Recruited

10,700+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Citations

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

Antibiotic prophylaxis in stone surgery: a systematic review ... A prophylactic regimen consisting of a single dose of ciprofloxacin infusion during surgery induction showed a higher efficacy as a preoperative ...

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

A Multicenter Randomized Controlled Trial of Antimicrobial ... The trial results demonstrate that antibiotic prophylaxis with single-dose ciprofloxacin probably reduces postprocedural infections, including ...

3. europeanurology.com europeanurology.com/article/S0302-2838(25)00506-8/pdf

A Multicenter Randomized Controlled Trial of Antimicrobial ... Our trial establishes the impact of ciprofloxacin; assessment of the efficacy of other antibiotics was beyond the scope of the study.

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

Antibiotic Prophylaxis With Routine Ureteral Stent Removal This study will be a single-institutional randomized, single-blinded prospectively controlled clinical trial of a single dose of Ciprofloxicin 500mg antibiotic ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.03.09.25323609v1.full-text

A Multicentre Randomised Controlled Trial Assessing the ... In this context, the APPEAL trial will compare the efficacy of single-dose ciprofloxacin antibiotic prophylaxis with placebo in preventing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5297569/

Acute kidney injury due to ciprofloxacin for treatment of ... Khan et al reported a case of “an elderly woman who developed oliguric acute kidney injury (AKI) after receiving oral and intravenous ciprofloxacin in a 48-hour ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11701592/

An exploratory study evaluated the 30 most commonly ... This research project aimed to identify and analyze the top 30 drugs most commonly associated with kidney stone formation using data from ...

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

Antibiotic Prophylaxis Cuts Infection Risk After Shockwave ... The final analysis included 840 patients treated with ciprofloxacin and 854 treated with placebo. Of the cohort, 74% had kidney stones and 26% ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924000949

Effects of Medications on the in vitro Growth of Gut Bacteria ... Here, we determine the effect of commonly prescribed medications that have been associated with kidney stones 3 , 5 , 6 on the growth of selected oxalate- ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/ciprofloxacin-oral-route/description/drg-20072288

Ciprofloxacin (oral route) - Side effects & dosage Use of ciprofloxacin 1000 mg extended-release tablet is not recommended in patients with severe kidney disease.