Oral Fosfomycin versus Ciprofloxacin for Febrile Urinary Tract Infection in Men: a pilot study

Recruiting

Conditions: rinary tract infections

Registration Number: NL-OMON22870

Lead Sponsor: one

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical cure rate (i.e., resolution of symptoms and fever) among evaluable patients through the 10- to 18-day posttherapy visit.

Secondary Outcome Measures

Name	Time	Method
10-18 days post-treatment:<br>- bacteriologic cure rate i.e. urine culture<br>- all-cause mortality<br>- adverse events<br>70- to 84 days post-treatment:<br>- clinical cure rate<br>- all-cause mortality<br>- relapse rate of UTI<br><br>- The plasma concentration of fosfomycin (mg/L) + 1, 1.5, 3, 5, and 8 hours after<br>the first study administration<br>- The plasma concentration of fosfomycin (mg/L) just before, +1, 1.5, 2, 3 hours<br>after third study administration or later<br>- The urine concentration of fosfomycin (mg/L), as measured following the<br>methods (section 5) 1-24 hours after the first study administration<br>- The urine concentration of fosfomycin (mg/L) 48-72 hours after the first study<br>administration or later