E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cystitis without tissue invasion (uncomplicated cytitis) |
Blaasontsteking zonder weefselinvasie (ongecompliceerde blaasontsteking) |
|
E.1.1.1 | Medical condition in easily understood language |
Cystitis without tissue invasion (uncomplicated cytitis) |
Blaasontsteking zonder weefselinvasie (ongecompliceerde blaasontsteking) |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
De microbiologische effectiviteit (negatieve follow-up sample 14 dagen na start antibiotica) van fosfomycine ten opzichte van nitrofurantoine in Nederlandse risicogroepen met een blaasontsteking zonder tekenen van weefselinvasie. |
|
E.2.2 | Secondary objectives of the trial |
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. |
Het klinisch genezingspercentage van fosfomycine en nitrofurantoine (verdwijnen van de symptomen). Het bepalen van de bijwerkingen geassocieerd met fosfomycine en nitrofurantoine. Het bepalen van de prevalentie van BRMOs (Bijzonder Resistente Micro-Organismen) in uropathogenen. Het bepalen van de resistentie percentages tegen de volgende antibiotica: Ampicilline, Amoxicilline/Clavulaanzuur (augmentin), Cefuroxim, Cefotaxim, Gentamicine, Tobramycine, Ciprofloxacine, Norfloxacine, Trimethoprim, Nitrofurantoine, Fosfomycine, Trimethoprim/sulfamethoxazol (co-trimoxazole) Het bepalen van de verdeling in micro-organismen in uropathogenen Het bepalen van het gebruiksgemak van fosfomycine en nitrofurantoine Het bepalen van de compliance van het gebruik van fosfomycine en nitrofurantoine Het identificeren van verschillen in risicogroepen van bovenstaande objectives |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
Patienten die zich presenteren bij hun huisarts met tekenen van een blaasonsteking zonder tekenen van weefselinvasie en behoren tot een NHG gedefinieerde risicogroep. NHG risicogroepen zijn: zoals mannen, zwangeren, patiënten met diabetes mellitus of een verminderde weerstand, patiënten met een verblijfskatheter en patiënten met bestaande afwijkingen aan nieren of urinewegen. |
|
E.4 | Principal 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. |
De patiënt is bekend met nierfalen (MDRD < 60 ml/ml). De patiënt is in het afgelopen jaar behandeld voor een urineweginfectie met resistentie tegen nitrofurantoine of fosfomycine. De patiënt is bekend met eerdere complicaties door nitrofurantoine of fosfomycine (denk aan allergische reacties, neuropathie, long/lever reacties en/of overgevoeligheid). De patiënt is bekend met een G6PD-deficiëntie, fructose-intolerantie, glucose-galactose-malabsorptie, sucrase-isomaltase-insufficiëntie, acute porfyrie en/of jicht. De patiënt wordt gedialyseerd, behandeld met andere antibiotica en/of gebruikt alkaliserende middelen. De patiënt is zwanger en bevindt zich in het eerste trimester (week 1 t/m 13) of bevindt zich in de periode vlak voor/tijdens de bevalling. De patiënt is niet wilsbekwaam. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparable microbiological eradication percentage of fosfomycin in comparison to nitrofurantoin |
Vergelijkbaar microbiologisch eradicatie percentage van fosfomycine ten opzichte van nitrofurantoine |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
14 days after start of the antibiotic treatment |
14 dagen na start antibiotica |
|
E.5.2 | Secondary end point(s) |
Comparable rates of the secondary objectives between fosfomycin and nitrofurantoin |
Vergelijkbare percentages van de secondary endpoints tussen fosfomycine en nitrofurantoine |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
14 days after start of the antibiotic treatment |
14 dagen na start antibiotica |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Resistance percentages |
Resistentie percentages |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
When 50 eligible patients are included and/or one year after the start date of the trial |
Wanneer er 50 patienten zijn geincludeerd en/of er een loopdatum van 1 jaar is bereikt |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |