Antibiotic Prophylaxis Before Shock Wave Lithotripsy

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.

Conditions

• Ureteral Stones
• Ureteral Calculi
• Nephrolithiasis

Interventions

DRUG

Ciprofloxacin

Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.

DRUG

Placebo

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.

Sponsors & Collaborators

• University of Helsinki

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Western University, Canada

  collaborator OTHER

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  collaborator OTHER

• King Abdulaziz University

  collaborator OTHER

• Hospital Sao Luiz

  collaborator OTHER

• St. Petersburg State Pavlov Medical University

  collaborator OTHER

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Tallaght University Hospital

  collaborator OTHER

• Tabriz University of Medical Sciences

  collaborator OTHER

• Dr Cipto Mangunkusumo General Hospital

  collaborator OTHER

• Clinical Urology and Epidemiology Working Group

  lead OTHER_GOV

Principal Investigators

• Kari AO Tikkinen, MD PhD · University of Helsinki

• Philippe D Violette, MD CM · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-27

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Brazil
• Canada
• Finland
• Indonesia
• Iran
• Ireland
• Russia
• Saudi Arabia
• Switzerland

Study Locations