Antibiotics Prophylaxis Before Shock Wave Lithotripsy (AAPEAL)

Phase 1

Conditions: ephrolithiasis
MedDRA version: 20.0Level: LLTClassification code 10046574Term: Urinary tract infection NOSSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2021-001486-21-IE

Lead Sponsor: niversity of Helsinki/CLUE working Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

Adult patients (=18 years)
Urolithiasis (i.e nephrolithiasis and/or ureterolithiasis)
Planned SWL
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Pre-SWL urine analysis positive for nitrites
? Pre-SWL urine culture reveals >105 CFU/ml of bacteria (positive urine culture)
? Taking antibiotics for 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 ? Breastfeeding people

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary goal of our study is to evaluate the impact of antibiotic prophylaxis on the rate of bacteriuria, symptomatic UTI, pyelonephritis and urosepsis among patients with sterile urine undergoing SWL.;Secondary Objective: Our secondary goal is to determine pre-procedural characteristics that can define patient subgroups with the greatest benefit from prophylactic antibiotics.;Primary end point(s): Our primary outcome will be a composite endpoint comprised of:<br>? Positive post-SWL urine culture (= 105 CFU/ ml), symptoms of cystitis (defined as<br>new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever =38.5 C).;Timepoint(s) of evaluation of this end point: 10 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Our secondary outcomes will be:<br>? Bacteriuria at 7-14 days post-SWL (=105 cfu/ml)<br>? Symptoms of cystitis (new onset burning sensation or pain with voiding,<br>frequency, urgency)<br>? Pyelonephritis or urosepsis (hospital admission with fever =38.5C) ? Change in IPSS score at 2 weeks (reported as a numerical value);Timepoint(s) of evaluation of this end point: 14 days