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

Antibiotic Prophylaxis Before Shock Wave Lithotripsy

Sponsors

Lead sponsor: Clinical Urology and Epidemiology Working Group

Collaborator: University of Western Ontario, Canada
Hospital District of Helsinki and Uusimaa
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
King Abdulaziz University
Hospital Sao Luiz

Source Clinical Urology and Epidemiology Working Group
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.

Overall Status Recruiting
Start Date September 27, 2018
Completion Date December 31, 2024
Primary Completion Date December 31, 2024
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis 7-14 days post-shockwave lithotripsy
Secondary Outcome
Measure Time Frame
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
Pain scale determined on a range of 0-5 with higher score indicating worse outcome 14 days post-shockwave lithotripsy
Enrollment 1500
Condition
Intervention

Intervention type: Drug

Intervention name: Ciprofloxacin

Description: Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.

Arm group label: ciprofloxacin

Other name: Cipro

Intervention type: Drug

Intervention name: Placebo

Description: 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.

Arm group label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Kari Tikkinen, MD

Phone: +358-50-5250971

Email: [email protected]

Location
facility status contact
Hospital Sao Luiz | São Paulo, 05605-050, Brazil Not yet recruiting Murilo Luz, MD [email protected]
University of Sherbrooke | Sherbrooke, Quebec, J1H 5H3, Canada Recruiting Patrick Richard, MD [email protected]
Helsinki University Hospital | Helsinki, 00029, Finland Recruiting Kari Tikkinen, MD +358505250971 [email protected]
King Abdulaziz University | Jeddah, 22252, Saudi Arabia Not yet recruiting Raed Ahzar, MD [email protected]
Location Countries

Brazil

Canada

Finland

Saudi Arabia

Verification Date

October 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Clinical Urology and Epidemiology Working Group

Investigator full name: Kari Tikkinen

Investigator title: Adjunct Professor, Departments of Urology and Public Health, Helsinki University Hospital and University of Helsinki

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: ciprofloxacin

Arm group type: Experimental

Description: Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: 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.

Acronym APPEAL
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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.

Source: ClinicalTrials.gov