E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
recurrent urinary tract infection in women |
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E.1.1.1 | Medical condition in easily understood language |
recurrent urinary tract infection in women |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
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 |
To investigate if taking methenamine hippurate reduce the need for antibiotic usage due to recurrent UTI (meassured as the number of courses of antibiotics) |
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E.2.2 | Secondary objectives of the trial |
-To investigate if methenamine hippurate will have a prolonged effect on antibiotic usage even after discontinuation. -To investigate if taking methenamine Hippurate reduces the incidence of UTI -To investigate if methenamine hippurate can reduce severity of UTI symptoms. -To investigate if methenamine hippurate can reduce duration of UTI episodes. -To investigate if number of complications such as pyelonephritis and hospital admission for UTI differ between methenamine hippurate and placebo. - To investigate if phylogenetic subgroups of E. coli found at inclusion is an effect modifier in the above outcomes
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• woman • age ≥70 years • recurrent UTIs defined as ≥3 episodes of antibiotic treated acute cystitis (acute symptoms specific/related to the urinary tract) during the last twelve months or ≥2 episodes during the last 6 months • able and willing to comply with all trial requirements • able and willing to give informed consent
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E.4 | Principal exclusion criteria |
• the patient has taken methenamine hippurate within the last 12 months • the patient is allergic to methenamine hippurate • the patient is having current antibiotic prophylaxis for UTI • the patient has a urinary catheter (chronic indwelling catheters as well as intermittent urinary catheterisation) • the patient has known severe chronic renal failure or estimated creatinine glomerular filtration rate ≤30 ml/min (known = registered in GP’ clinical records) • the patient has a known condition or treatment associated with significant impaired immunity (e.g. long-term oral steroids, chemotherapy, or immune disorder) (known = registered in GP clinical records) • the patient has a known severe hepatic impairment (known = registered in GP clinical records) • the patient is suffering from severe dehydration • the patient has shown signs of gout • the patient has a need for long term use of antacids such as magnesium hydroxide, magnesium carbonate, aluminium hydroxide • the patient has a life expectancy estimated by a clinician to be less than six months • the patient has been involved in, including completion of, follow-up procedures, in another clinical trial of an investigational medicinal product in the last 90 days • the patient suffers from incontinence too severe to be able to provide a voided urine specimen • the patient is participating in ImpresU Work Package 2 • the patient is suffering from significant known abnormal renal tract anatomy/physiology (i.e. single kidney, persistent urinary tract stone disease, severe vesicoureteral reflux) or neuropathic bladder disorders • the patient has lactose intolerance.
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of antibiotic courses during the first half year of treatment |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After six months of treatment. |
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E.5.2 | Secondary end point(s) |
2a. Number of UTI antibiotic treatments during the six months following completion of the trial. 2b. Number of UTIs (acute symptoms specific/related to the urinary tract) during the six months of treatment |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2a. Six months after completion (12 months after commencing treatment) 2b. After six months of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | Yes |
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
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The study ends when the last follow up is made for all included participants |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |