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

Phase 4

Recruiting

Conditions: Cystitis and uncomplicated urinary tract infection
10004018

Registration Number: NL-OMON45847

Lead Sponsor: Streeklaboratorium voor de volksgezondheid Kennemerland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

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.

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 earlier complications towards nitrofurantoin and/or fosfomycin such as allergic reactions, hypersensitivity peripheral neuropathy and/or lung and liver reactions.
Patients known with Glucose-6-phosphate dehydrogenase deficiency, fructose intolerance, glucose-galactose malabsorption, sucrase-isomaltase insufficiency, acute porphyria or gout.
Patients using other antibiotics and/or using alkalizing agents.
For pregnant women: is in the first trimester of pregnancy (week 1 to 13) or in the period of delivery (after the first contractions).
Patients who refuse or are unable to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The microbiological effectiveness (negative follow-up sample 14 days after<br /><br>antibiotic treatment) of fosfomycin in reference to nitrofurantoin in Dutch<br /><br>risk groups with a cystitis without signs of tissue invasion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the clinical cure rate of fosfomycin and nitrofurantoin<br /><br>(elimination of symptoms).<br /><br>To determine side effects of fosfomycin and nitrofurantoin.<br /><br>To determine the prevalence of MDROs (multi-drug resistant microorganisms) in<br /><br>uropathogens.<br /><br>To determine the resistance rates towards the following antibiotics:<br /><br>Ampicillin, Amoxicillin/clavulanic acid (augmentin), Cefuroxime, Cefotaxime,<br /><br>Gentamicin, Tobramycin, Ciprofloxacin, Norfloxacin, Trimethoprim,<br /><br>Nitrofurantoin, Fosfomycin, Trimethoprim/sulfamethoxazole (co-trimoxazole)<br /><br>To determine the distribution of microorganisms in uropathogens.<br /><br>To determine the ease of use of fosfomycin and nitrofurantoin.<br /><br>To determine the compliance of fosfomycin and nitrofurantoin.<br /><br>To determine differences in risk groups between the above mentioned objectives.</p><br>