E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of urinary tract infections among patients undergoing extracorporeal shock wave lithotripsy for urinary stone disease |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of urinary tract infections among patients undergoing extracorporeal shock wave lithotripsy for urinary stone disease |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046574 |
E.1.2 | Term | Urinary tract infection NOS |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Secondary goal is to determine pre-procedural characteristics that can define patient subgroups with the greatest benefit from prophylactic antibiotics. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients (aged 18 years or older) undergoing extracorporeal shock wave lithotripsy for urinary stone disease |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | 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).
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |