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

Phase 3

Recruiting

Conditions: urinary tract infection
10004018
10046590

Registration Number: NL-OMON55825

Lead Sponsor: HagaZiekenhuis

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 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the clinical cure rate (resolution of symptoms) 10 to<br /><br>18 days post-treatment (= test of cure, TOC). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are clinical cure rate during late follow-up (LFU, 70 to 84<br /><br>days post-treatment), microbiological cure rate, time to resolution of<br /><br>symptoms, rate of UTI relapse, rate of adverse events and the pharmacokinetic<br /><br>profile of fosfomycin. </p><br>