Antibiotic Prophylaxis for Kidney Stones

(APPEAL Trial)

Recruiting at 9 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

1732 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Research Team

Philippe D Violette, MD CM

Principal Investigator

McMaster University

Kari AO Tikkinen, MD PhD

Principal Investigator

University of Helsinki

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+