CompletedPhase 4

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Brazil, Canada, Finland1,732 participantsStarted 2018-09-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis

Timeframe: 7-14 days post-shockwave lithotripsy

Trial details

NCT IDNCT03692715

SponsorClinical Urology and Epidemiology Working Group

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Ureteral Stones trials