Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25027
Enrollment
30
Registered
2018-02-21
Start date
2018-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile urinary tract infection in men

Interventions

Men with febrile urinary tract infection who are admitted for empirical intravenous antibiotic treatment will be switched to oral fosfomycin for a total treatment duration of 14 days

Sponsors

Haga Teaching Hospital
Lead Sponsor

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 -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

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the clinical cure rate 10-18 days post-treatment.

Secondary

MeasureTime frame
Test of Cure (10-18 days post-treatment): " bacteriologic cure rate " all-cause mortality " adverse events Late follow up (70- to 84 days post-treatment): " clinical cure rate " all-cause mortality " relapse rate of UTI

Contacts

Public ContactC. Nieuwkoop, van

Haga Teaching Hospital, Dept. of Internal Medicine

c.vannieuwkoop@hagaziekenhuis.nl+31-70-2105561

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)