Antibiotic Prophylaxis Before Shock Wave Lithotripsy

NCT ID: NCT03692715

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1732 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2024-12-31

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.

Detailed Description

This is a two arm, double blind randomized controlled trial (RCT) comparing the use of a single dose ciprofloxacin prior to shock wave lithotripsy (SWL) to placebo. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

Eligibility criteria include patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria (outlined below).

Eligible patients will provide written informed consent. Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.

Patients will undergo SWL using standard procedures at the participating center. Participants will asked to provide a pre-procedure study questionnaire, a modified International Prostate Symptom Score (IPSS) questionnaire and a urine sample for analysis prior to SWL and follow-up. Follow-up questionnaires and a requisition for urine culture will be provided in a pre-stamped, self-addressed envelope along with instructions to return both culture and questionnaires to their participating center at 7-14 days post-SWL. If the follow-up questionnaire has not been received by post-operative day 10 patients will receive a reminder phone call. A second envelope will be sent containing a requisition for urine culture and follow-up questionnaire when necessary.

Alternatively, if a 2 week follow-up is conducted at the participating site then data-forms can be completed and collected at that time. In the event that a urine culture was not submitted 7 days post-operatively, one can be collected up to 14 days post-op. Additional clinical parameters such as presence of double J, stone characteristics and renal insufficiency will be recorded at the time of SWL by the dedicated research staff at the participating center. Data acquisition and occurrence of outcomes will be monitored continuously with scheduled audits.

Primary and secondary outcomes are outlined below.

The power calculation for this protocol was performed using Stata v.10.1 (StataCorp, College Station, TX). The investigators used the American Urological Association Best Practice Statement on antibiotic prophylaxis to estimate a 60% relative risk reduction with treatment arm. Therefore to achieve a power of 90% with a significance level of p<0.05, 661 patients will need to be recruited in each arm for a total of 1,322 patients. Accounting for 10% loss to follow-up, the total required will be 1454, or approximately 1500 patients. Assuming that 25% of patients screened will either refuse to be randomized or will meet one of the pre-defined exclusion criteria, a minimum of 2000 patients will need to be screened in order to randomize 1500 patients.

Conditions

Ureteral Stones; Ureteral Calculi; Nephrolithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ciprofloxacin

Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy

Group Type: EXPERIMENTAL

Ciprofloxacin

Intervention Type: DRUG

Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Ciprofloxacin

Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Cipro

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Western University, Canada

OTHER

Sponsor Role: collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

King Abdulaziz University

OTHER

Sponsor Role: collaborator

Hospital Sao Luiz

OTHER

Sponsor Role: collaborator

St. Petersburg State Pavlov Medical University

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: collaborator

Tallaght University Hospital

OTHER

Sponsor Role: collaborator

Tabriz University of Medical Sciences

OTHER

Sponsor Role: collaborator

Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role: collaborator

Clinical Urology and Epidemiology Working Group

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kari Tikkinen

Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kari AO Tikkinen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Philippe D Violette, MD CM

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Hospital Sao Luiz

São Paulo, , Brazil

Western University Hospital

London, Ontario, Canada

University of Sherbrooke

Sherbrooke, Quebec, Canada

Helsinki University Hospital

Helsinki, , Finland

Universitas Indonesia - Cipto Mangunkusumo Hospital

Jakarta, , Indonesia

Tabriz University of Medical Science

Tabriz, , Iran

Tallaght University Hospital

Dublin, , Ireland

St Petersburg State Pavlov Medical University

Saint Petersburg, , Russia

King Abdulaziz University

Jeddah, , Saudi Arabia

Department of Urology, University Hospital Basel

Basel, , Switzerland

Countries

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

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Informed consent form Generic

View Document

Other Identifiers

CLUE

Identifier Type: -

Identifier Source: org_study_id