Antibiotic Prophylaxis Before Shock Wave Lithotripsy

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Urology and Epidemiology Working Group
• Collaborators: Centre de recherche du Centre hospitalier universitaire de Sherbrooke; Dr Cipto Mangunkusumo General Hospital; Helsinki University Central Hospital; Hospital Sao Luiz; King Abdulaziz University; St. Petersburg State Pavlov Medical University; Tabriz University of Medical Sciences; Tallaght University Hospital; University Hospital, Basel, Switzerland; University of Helsinki; University of Western Ontario, Canada
• Treatments: Ciprofloxacin

Criteria

Inclusion Criteria:

Patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria.

Exclusion Criteria:

• Pre-SWL urine analysis positive for nitrites

• Pre-SWL urine culture reveals >10e5 Colony Forming Unit/ml of bacteria (positive urine culture)

• Taking antibiotics for Urinary Tract Infection (UTI) or other cause

• Suspected struvite stone (based on previous stone analysis, or partial staghorn)

• Presence of nephrostomy tube

• Requiring cystoscopy and ureteral stent insertion on the day of SWL

• Presence of Foley catheter or patient on regular clean intermittent catheterization (CIC)

• Presence of urinary diversion (ie: ileal conduit)

• History of urosepsis prior to SWL

• Known allergic reaction to trial antibiotic

• Previous randomization in this trial

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