Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Kari Tikkinen，Clinical Urology and Epidemiology Working Group

Tracking Information

First Submitted Date ^ICMJE

August 21, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

September 27, 2018

Estimated Primary Completion Date

December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis[ Time Frame: 7-14 days post-shockwave lithotripsy ]

The composite outcome with be assessed as a dichotomous variable. The presence of Positive post-SWL urine culture (≥ 10e5 Colony Forming Unit/ ml), with 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml[ Time Frame: 7-14 days post-shockwave lithotripsy ]
Bacteriuria will be assessed as a dichotomous variable with presence of is ≥100000 Colony Forming Unit/ml will be considered as an event
Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency[ Time Frame: 7-14 days post-shockwave lithotripsy ]
Symptoms of cystitis will be considered as a dichotomous variable with new onset burning sensation or pain with voiding, frequency, urgency will be considered an event
Pyelonephritis or urosepsis defined as Hospital admission with fever ≥38.5 Celsius[ Time Frame: 7-14 days post-shockwave lithotripsy ]
Pyelonephritis or urosepsis will be assessed as a dichotomous variable with Hospital admission with fever ≥38.5 Celsius will be considered as an event
Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome)[ Time Frame: 14 days post-shockwave lithotripsy ]
Change in total value of IPSS score will be assessed as a continuous variable with a range from 0-35 with higher scores indicating more severe symptoms. This score is calculated by summation of individual component scores (0-5) across 7 domains
Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome)[ Time Frame: 14 days post-shockwave lithotripsy ]
Individual IPSS domains will be assessed as continuous variables and include incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Higher scores as considered as more severe symptoms
Pain scale determined on a range of 0-5 with higher score indicating worse outcome[ Time Frame: 14 days post-shockwave lithotripsy ]
Pain scale will be assessed as a continuous variable. The scale will be elicited by asking In the past week, how often have you had burning or discomfort with urination? Higher score is considered as more severe symptoms

Descriptive Information

Brief Title ^ICMJE

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Official Title ^ICMJE

A Multicenter Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: ciprofloxacin
Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy
Placebo Comparator: 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

1500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2024

Estimated Primary Completion Date

December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Kari Tikkinen，Clinical Urology and Epidemiology Working Group

Study Sponsor ^ICMJE

Clinical Urology and Epidemiology Working Group

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Philippe D Violette, MD McMaster University
Study Director: Patrick Richard, MD Université de Sherbrooke
Study Director: Murilo Luz, MD Hospital Sao Luiz
Study Director: Raed Ahzar, MD King Abdulaziz University

PRS Account

Clinical Urology and Epidemiology Working Group

Verification Date

August 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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