E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent uncomplicated urynary tract infections |
Infezioni delle vie urinarie recidivanti non complicate |
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E.1.1.1 | Medical condition in easily understood language |
Urinary tract infections |
Infezioni delle vie urinarie |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038140 |
E.1.2 | Term | Recurrent urinary tract infection |
E.1.2 | System Organ Class | 100000004862 |
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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 evaluate in female patients pidotimod effects on relapse number prevention of the Urinary Tract Infection (UTI), symptomatic and uncomplicated. |
Valutare in pazienti di genere femminile gli effetti di pidotimod sulla prevenzione del numero di recidive di Infezioni delle Vie Urinarie (IVU), sintomatiche e non complicate. |
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E.2.2 | Secondary objectives of the trial |
- to assess the disappearance time of dysuria after the acute phase - to assess the average time of first relapse - to assess the frequency of patients who relapse at least once in the 12 months of the study - to evaluate the metabolic profile of urine before and after the treatment with pidotimod/placebo in 50% of the randomized population |
- valutare il tempo di scomparsa della disuria dopo la fase acuta - valutare il tempo medio di prima recidiva - valutare la frequenza di Pazienti che recidiva almeno una volta nei 12 mesi di studio - valutare il profilo metabolico delle urine prima e dopo trattamento con pidotimod/placebo nel 50% della popolazione randomizzata |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients who will be included in the study: - female patients in menopausal status (12 months of amenorrhea) and under 75 years; - uncomplicated symptomatic UTI; - documented bacteriuria (> 10^5 per ml of bacterial colonies); - antibiogram available no more than 5 days before enrollment; - with at least 3 episodes of UTI (symptomatic, non-complicated) in the 12 months before the enrollment or at least 2 episodes in the 6 months before; - able to be contacted by telephone during the follow-up phase period; - who have understood and signed the informed consent and release for use of sensitive data. |
Potranno essere incluse nello studio pazienti: - di sesso femminile, in menopausa (12 mesi di amenorrea) e di età inferiore ai 75 anni; - IVU sintomatica non complicata; - batteriuria documentata (> 10^5 per ml di colonie batteriche); - antibiogramma antecedente di non più di 5 gg l’arruolamento; - con almeno 3 episodi di IVU (sintomatica, non complicata) nei dodici mesi precedenti l’arruolamento o almeno 2 episodi nei 6 mesi precedente; - in grado di essere contattate telefonicamente nel periodo della fase di follow up - che hanno compreso e firmato il consenso informato e la liberatoria per l’utilizzo dei dati sensibili. |
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E.4 | Principal exclusion criteria |
Patients who will not be included in the study: - over 75 years or not in menopausal status or amenorrhea <12 months; - with diabetic diseases; - with congenital or acquired immunodeficiency; - diagnosed or recurrent cancer disease in the last five years; - treated with immunomodulators (immunosuppressants or immunostimulants), corticosteroids (only under systemic chronic treatment); - with hyper-IgE syndromes; - atopic subjects or with a history of allergic reactions; - with allergies or intolerances to Pidotimod and/or to the excipients; - compliance with negative features. |
Non saranno ammesse allo studio pazienti: - di età > 75 aa o non in menopausa o con amenorrea < ai 12 mesi; - con patologie diabetica; - con immunodeficienza congenita o acquisita; - con diagnosi o recidiva di patologia oncologica negli ultimi 5 anni; - in trattamento con immunomodulatori (immunosoppressori o immunostimolanti), cortisonici (solo sistemici in trattamento cronico); - con sindromi da iper-IgE; - soggetti atopici o con precedenti di reazioni allergiche; - con allergie o intolleranze al Pidotimod e/o agli eccipienti; - con caratteristiche di compliance negativa. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of relapses of UTI in the following 12 months confirmed by positive urine culture (bacteriuria > 10^5 per ml of bacterial colonies) |
Numero di recidive di IVU nei 12 mesi successivi confermate da urinocoltura positiva (batteriuria: > 10^5 per ml di colonie batteriche)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Disappearance time of dysuria after the acute phase - Average time of relapse - Number of patients with at least 1 relapse in the 12 months following the enrolment - Metabolomic parameters |
- Tempo di scomparsa della disuria dopo la fase acuta - Tempo di ricomparsa della recidiva - N¿ di Pz con almeno una recidiva nei 12 mesi successivi l¿arruolamento - Parametri metabolomici |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |