Urinary tract infections
Conditions
Interventions
Oral fosfomycin 3 gram each 24 hours with duration of 14 days minus days of intravenous antibiotic,
Sponsors
None
Eligibility
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 beta-lactams 6. Positive urine (> 103 CFU/ml) culture and/or blood culture with E. coli susceptible to fosfomycin, ciprofloxacin and the empirical intravenous beta-lactam treatment 7. Fullfilment 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 Specific exclusion criteria for the FOS-MEN-pharm substudy is 1. Incontinency for urine, which results in the inability to properly get urine samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate (i.e., resolution of symptoms and fever) among evaluable patients through the 10- to 18-day posttherapy visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 10-18 days post-treatment: - bacteriologic cure rate i.e. urine culture - all-cause mortality - adverse events 70- to 84 days post-treatment: - clinical cure rate - all-cause mortality - relapse rate of UTI - The plasma concentration of fosfomycin (mg/L) + 1, 1.5, 3, 5, and 8 hours after the first study administration - The plasma concentration of fosfomycin (mg/L) just before, +1, 1.5, 2, 3 hours after third study administration or later - The urine concentration of fosfomycin (mg/L), as measured following the methods (section 5) 1-24 hours after the first study administration - The urine concentration of fosfomycin (mg/L) 48-72 hours after the first study administration or later | — |
Contacts
Public ContactSander Kuiper
LUMC / Haga Ziekenhuis
Outcome results
None listed