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

• Register: EUCTR
• Last refreshed on: 4 July 2016
• Main ID: EUCTR2016-001427-30-FI
• Date of registration: 23/06/2016
• Prospective Registration: Yes
• Primary sponsor: University of Helsinki / CLUE Working Group
• Public title: Antibiotic treatment before extracorporeal shock wave lithotripsy to prevent urinary tract infection
• Scientific title: Antibiotic prophylaxis before extracorporeal shock wave lithotripsy (APPEAL) - APPEAL
• Date of first enrolment: 28/06/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001427-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Finland

Contacts

• Name: Kari Tikkinen
• Affiliation: University of Helsinki / CLUE Working Grouå

• Name: Kari Tikkinen
• Affiliation: University of Helsinki / CLUE Working Grouå

Key inclusion & exclusion 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 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

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

Intervention(s)

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 the placebo: Oral use

Primary Outcome(s)

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.

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).

Secondary Objective: Secondary goal is to determine pre-procedural characteristics that can define patient subgroups with the greatest benefit from prophylactic antibiotics.

Timepoint(s) of evaluation of this end point: 7-14 days post-SWL

Secondary Outcome(s)

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

Secondary ID(s)

276046

Source(s) of Monetary Support

University of Helsinki / CLUE Working Grouå