Nephrolithiasis Clinical Trial
— APPEALOfficial title:
A Multicenter Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Sao Luiz | São Paulo | |
Canada | Western University Hospital | London | Ontario |
Canada | University of Sherbrooke | Sherbrooke | Quebec |
Finland | Helsinki University Hospital | Helsinki | |
Indonesia | Universitas Indonesia - Cipto Mangunkusumo Hospital | Jakarta | |
Iran, Islamic Republic of | Tabriz University of Medical Science | Tabriz | |
Ireland | Tallaght University Hospital | Dublin | |
Russian Federation | St Petersburg State Pavlov Medical University | Saint Petersburg | |
Saudi Arabia | King Abdulaziz University | Jeddah | |
Switzerland | Department of Urology, University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
Clinical Urology and Epidemiology Working Group | Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Dr Cipto Mangunkusumo General Hospital, Helsinki University Central Hospital, Hospital Sao Luiz, King Abdulaziz University, St. Petersburg State Pavlov Medical University, Tabriz University of Medical Sciences, Tallaght University Hospital, University Hospital, Basel, Switzerland, University of Helsinki, University of Western Ontario, Canada |
Brazil, Canada, Finland, Indonesia, Iran, Islamic Republic of, Ireland, Russian Federation, Saudi Arabia, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Bacteriuria defined as = 100000 Colony Forming Unit/ml | Bacteriuria will be assessed as a dichotomous variable with presence of is =100000 Colony Forming Unit/ml will be considered as an event | 7-14 days post-shockwave lithotripsy | |
Secondary | Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency | 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 | 7-14 days post-shockwave lithotripsy | |
Secondary | Pyelonephritis or urosepsis defined as Hospital admission with fever =38.5 Celsius | Pyelonephritis or urosepsis will be assessed as a dichotomous variable with Hospital admission with fever =38.5 Celsius will be considered as an event | 7-14 days post-shockwave lithotripsy | |
Secondary | Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome) | 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 | 14 days post-shockwave lithotripsy | |
Secondary | Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome) | 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 | 14 days post-shockwave lithotripsy | |
Secondary | Pain scale determined on a range of 0-5 with higher score indicating worse outcome | 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 | 14 days post-shockwave lithotripsy |
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