Antibiotics Prophylaxis Before Shock Wave Lithotripsy (AAPEAL)

A Multicentre Randomised Control Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on reducing Urinary Tract Infections - APPEAL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001486-21-IE

Enrollment

1500

Registered

2021-07-07

Start date

2021-11-26

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrolithiasis MedDRA version: 20.0 Level: LLT Classification code 10046574 Term: Urinary tract infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Ciprofloxacin 2 mg/ml Solution for infusion PL 24598/0009 Product Name: Ciprofloxacin Product Code: PL 24598/0009 Pharmaceutical Form: Infusion INN or Proposed INN: Ciprofloxacin CAS Num

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: ? Positive post-SWL urine culture (= 105 CFU/ ml), 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).;Timepoint(s) of evaluation of this end point: 10 days	—

Measure

Time frame

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: ? Positive post-SWL urine culture (= 105 CFU/ ml), 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).;Timepoint(s) of evaluation of this end point: 10 days

—

Secondary

Measure	Time frame
Secondary end point(s): Our secondary outcomes will be: ? Bacteriuria at 7-14 days post-SWL (=105 cfu/ml) ? Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency) ? 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	—

Countries

Brazil, Canada, Indonesia, Ireland, Qatar, Russian Federation, Saudi Arabia, Switzerland

Contacts

Public Contactkari Tilkkinen

University of Helsinki/CLUE working group

kari.tikkinen@gmail.com+358505393222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026