urinary tract infection
Conditions
Interventions
After an empirical intravenous antibiotic treatment an iv-oral switch to oral 
fosfomycin 3000mg, every 24 hours, up to 14 days. Patients will be compared to 
historical controls who were included in a randomized trial with similar 
inclusion criteria and who were treated with oral ciprofloxacin. 
Eligible patients who refuse to be treated with fosfomycin, will be treated 
with ciprofloxacin. Those patients will be asked to participate in the trial 
for observational purposes only as they can serve as control patients as well.
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Competent male patient aged 18 years or above 2. One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain) 3. Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours 4. Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy 5. Hospital admission for presumed FUTI and empirical intravenous antibiotic treatment with b-lactams 6. Positive urine (> 103 CFU/ml) culture and/or blood culture with E. coli susceptible to fosfomycin, ciprofloxacin and the empirical intravenous -lactam treatment 7. Fulfilment of criteria for safe iv to oral switch (hemodynamic stability, ability to consume oral antibiotics, no gastrointestinal problems which affect absorption)
Exclusion criteria
Exclusion criteria: 1. Known allergy to fosfomycin or ciprofloxacin 2. Patients with known polycystic kidney disease 3. Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis) 4. Patients with history of kidney transplantation 5. Patients with a permanent urinary catheter 6. Patients with chronic renal failure (eGFR <30 ml/min/1.73m3) 7. Patients with renal abcess or pyonephrosis 8. Patients with chronic bacterial prostatitis (defined as recurrent UTI with the same uropathogen and no other clarifying underlying urological disorder) 9. Patients with any diagnosed metastatic E. coli foci 10. Patients with a double-J or nephrostomy catheter 11. Concomitant systemic antibiotic treatment for another reason than FUTI 12. Residence outside the Netherlands 13. Inability to speak or read Dutch , All participants at the Haga Teaching Hospital are also eligible for the pharmacokinetic part of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the clinical cure rate (resolution of symptoms) 10 to 18 days post-treatment (= test of cure, TOC). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are clinical cure rate during late follow-up (LFU, 70 to 84 days post-treatment), microbiological cure rate, time to resolution of symptoms, rate of UTI relapse, rate of adverse events and the pharmacokinetic profile of fosfomycin. | — |
Countries
Netherlands
Outcome results
None listed