Antibiotic Prophylaxis Before Shock Wave Lithotripsy

NCT03692715 | Completed Phase 4

• 1 other identifier: CLUE
• Study Type: interventional
• Target: 1,732
• Locations: 9 countries
• Sites: 10

Brief 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

Keywords

ureteral stones; ureteral calculi; shockwave lithotripsy

Outcome Measures

Primary Outcomes (1)

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

  The composite outcome with be assessed as a dichotomous variable. The presence of Positive post-SWL urine culture (≥ 10e5 Colony Forming Unit/ ml), with either one or more of symptoms of cystitis (defined as new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever ≥38.5 C) will be considered as an event.

  7-14 days post-shockwave lithotripsy

Secondary Outcomes (6)

• Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml

  7-14 days post-shockwave lithotripsy

• Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency

  7-14 days post-shockwave lithotripsy

• Pyelonephritis or urosepsis defined as Hospital admission with fever ≥38.5 Celsius

  7-14 days post-shockwave lithotripsy

• Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome)

  14 days post-shockwave lithotripsy

• Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome)

  14 days post-shockwave lithotripsy

Study Arms (2)

ciprofloxacin

EXPERIMENTAL

Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy

Drug: Ciprofloxacin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Ciprofloxacin DRUG

Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.

Also known as: Cipro

ciprofloxacin

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Hospital Sao Luiz

São Paulo, 05605-050, Brazil

Location

Western University Hospital

London, Ontario, N6C 2V5, Canada

Location

University of Sherbrooke

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Universitas Indonesia - Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

Tabriz University of Medical Science

Tabriz, Iran

Location

Tallaght University Hospital

Dublin, Ireland

Location

St Petersburg State Pavlov Medical University

Saint Petersburg, Russia

Location

King Abdulaziz University

Jeddah, 22252, Saudi Arabia

Location

Department of Urology, University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Ureteral Calculi; Nephrolithiasis

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Kidney Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kari AO Tikkinen, MD PhD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Philippe D Violette, MD CM

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: October 2, 2018
• Study Start: September 27, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); IR (1); CH (1); CA (2); SA (1); IE (1); FI (1); ID (1); RU (1)