Effectiveness of fosfomycin versus nitrofurantoin in Dutch risk groups with cystitis: a pilot study (Uri-weg study)

Phase 1

Conditions: Cystitis without tissue invasion (uncomplicated cytitis)
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2015-004297-14-NL

Lead Sponsor: Streeklaboratorium voor de volksgezondheid Kennemerland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients presenting to their GP with symptoms of cystitis belonging to a risk group (according to the NHG standard in 2013) without signs of tissue invasion, and have an indication for antibiotic treatment according to the GP. Dutch defined risk groups are defined by males, pregnant females, patients with diabetes mellitus, impaired immunity, abnormalities of the renal or urinary tract, neurological bladder dysfunction and/or an indwelling urinary catheter.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Patients with known renal dysfunction(s) (MDRD< 60 ml/min).
Patient is known with an uropathogen isolated in the past 12 months with resistance towards nitrofurantoin and/or fosfomycin.
Patient is known with complications towards nitrofurantoin and/or fosfomycin such as allergic reactions, peripheral neuropathy and/or lung and liver reactions.
Patients who are known hypersensitive towards nitrofurantoin, fosfomycin and / or one of the excipients.
Patients known with Glucose-6-phosphate dehydrogenase deficiency.
Patients with known fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Patients with known acute porphyria.
Patients with known gout.
Patients receiving hemodialysis.
Patients using other antibiotics.
Patients using alkalizing agents.
For pregnant women:
Is in the first trimester of pregnancy (week 1 to 13).
Is in the period of delivery (after the first contractions).
Patients who refuse or are unable to give informed consent.