Cystitis without tissue invasion (uncomplicated cytitis)
Conditions
Interventions
Trade Name: Monuril 3000, granulaat voor drank 3 g
Pharmaceutical Form: Granules for oral solution in sachet
Trade Name: Furabid, capsules met gereguleerde afgifte 100 mg
Pharmaceutical Form: Capsule
Sponsors
Streeklaboratorium voor de volksgezondheid Kennemerland
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The microbiological effectiveness (negative follow-up sample 14 days after antibiotic treatment) of fosfomycin in reference to nitrofurantoin in Dutch risk groups with a cystitis without signs of tissue invasion.;Secondary Objective: To determine the clinical cure rate of fosfomycin and nitrofurantoin (elimination of symptoms). To determine side effects of fosfomycin and nitrofurantoin. To determine the prevalence of MDROs (multi-drug resistant microorganisms) in uropathogens. To determine the resistance rates towards the following antibiotics: Ampicillin, Amoxicillin/clavulanic acid (augmentin), Cefuroxime, Cefotaxime, Gentamicin, Tobramycin, Ciprofloxacin, Norfloxacin, Trimethoprim, Nitrofurantoin, Fosfomycin, Trimethoprim/sulfamethoxazole (co-trimoxazole) To determine the distribution of microorganisms in uropathogens. To determine the ease of use of fosfomycin and nitrofurantoin. To determine the compliance of fosfomycin and nitrofurantoin. To determine differences in risk groups between the above mentioned objectives.;Primary end point(s): Comparable microbiological eradication percentage of fosfomycin in comparison to nitrofurantoin;Timepoint(s) of evaluation of this end point: 14 days after start of the antibiotic treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparable rates of the secondary objectives between fosfomycin and nitrofurantoin ;Timepoint(s) of evaluation of this end point: 14 days after start of the antibiotic treatment | — |
Countries
Netherlands
Contacts
Public ContactDennis Souverein
Streeklaboratorium voor de volksgezondheid Kennemerland
Outcome results
None listed