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

Phase 1

• Conditions: Febrile urinary tract infection; MedDRA version: 20.0Level: HLTClassification code 10046577Term: Urinary tract infectionsSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 21.1Level: PTClassification code 10052238Term: Escherichia urinary tract infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2017-004963-11-NL
• Lead Sponsor: Haga Teaching Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• 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 -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)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified