Antibiotic treatment before extracorporeal shock wave lithotripsy to prevent urinary tract infection

Antibiotic prophylaxis before extracorporeal shock wave lithotripsy (APPEAL) - APPEAL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001427-30-FI

Enrollment

Unknown

Registered

2016-06-23

Start date

2016-06-28

Completion date

Unknown

Last updated

2016-07-04

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

Conditions

Prevention of urinary tract infections among patients undergoing extracorporeal shock wave lithotripsy for urinary stone disease MedDRA version: 19.0 Level: LLT Classification code 10046574 Term: Urinary tract infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Ciproxin (ciprofloxacin 500 mg per oral) Product Name: Ciproxin Product Code: SUB01316MIG Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (aged 18 years or older) undergoing extracorporeal shock wave lithotripsy for urinary stone disease 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Exclusion criteria are: • Pre-shock wave lithotripsy (SWL) urine analysis positive for nitrites • Pre-SWL urine culture reveals >105 CFU/ml of bacteria (positive urine culture) • Taking antibiotics for urinary tract infection 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 • Presence of urinary diversion (ie: ileal conduit) • History of urosepsis prior to SWL • Known allergic reaction to trial antibiotic • Previous randomization in this trial

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: Secondary goal is to determine pre-procedural characteristics that can define patient subgroups with the greatest benefit from prophylactic antibiotics. ;Primary end point(s): 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: 7-14 days post-SWL	—

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: Secondary goal is to determine pre-procedural characteristics that can define patient subgroups with the greatest benefit from prophylactic antibiotics. ;Primary end point(s): 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: 7-14 days post-SWL

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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: 7-14 days post-SWL	—

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: 7-14 days post-SWL

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Countries

Finland

Contacts

Public ContactKari Tikkinen

University of Helsinki / CLUE Working Grouå

kari.tikkinen@gmail.com+358505393222

Outcome results

None listed

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