E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD) |
infezioni da Clostridium difficile (CDI ¿ Clostridium difficile infections) note anche come diarrea associata a C. difficile (CDAD ¿ C. Difficile ¿associated diarrhoea) |
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E.1.1.1 | Medical condition in easily understood language |
Infection of the gut caused by bacteria called Clostridium difficile |
Infezione dell'intestino causata da un batterio noto come Clostridium difficile |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022661 |
E.1.2 | Term | Intestinal infection due to clostridium difficile |
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 |
The primary objective of the study is to investigate the plasma pharmacokinetics (PK) of fidaxomicin and primary metabolite OP-1118 in Subjects with Inflammatory Bowel Disease (IBD) and C. difficile Infection on Day 1, Day 5 and Day 10 of treatment. |
L¿obiettivo primario dello studio ¿ quello di analizzare il profilo di farmacocinetica plasmatica (PK) della fidaxomicina (FDX) e del suo metabolita primario OP-1118 in soggetti affetti da Malattie Intestinale Infiammatoria (Inflammatory Bowel Disease, IBD) e Infezione da C. difficile (CDI) al Giorno 1, Giorno 5 e Giorno 10 di trattamento. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to: ¿ compare CDI clinical response to the microbiological response in terms of magnitude of reduction of C. diff total viable count and spore count during fidaxomicin treatment and if achieved, the time to microbial eradication ¿ determine time to negative CDI toxin assay in stool specimens during fidaxomicin treatment ¿ compare differences in fidaxomicin stool concentrations and metabolite OP-1118 throughout therapy from Day 1, Day 5 and Day 10 ¿ assess the length of hospital stay, readmissions and resource utilization for IBD patients receiving fidaxomicin throughout the study until Visit 8 (Day 180, EOS) ¿ record the incidence and severity of AEs up to EOS Visit 8 (Day 180) ¿ document impact of treatment on Quality of Life as measured by the changes in Short IBDQ score from Baseline Visit 1 to Visit 3 (Day 10), Visit 5 (Day 26), Visit 6 (Day 40) and Visit 7 (Day 90), EOS Visit 8 (Day 180) and to any confirmed recurrence episode |
¿confrontare la risposta clinica e microbiologica dell¿infezione da CDI in termini di entit¿ di riduzione della conta totale dei batteri vitali e delle spore di C. difficile durante il trattamento con FDX, e rilevare il tempo all¿eradicazione microbica, se ottenuta. ¿determinare il tempo necessario a ottenere la negativit¿ al test delle tossine di CDI nei campioni di feci in corso di trattamento con FDX ¿misurare le concentrazioni fecali di FDX e del suo metabolita OP-1118 nel corso della terapia, al Giorno 1, Giorno 5, Giorno 10 ¿valutare la durata della degenza ospedaliera, il numero di nuovi ricoveri e l¿utilizzo delle risorse nel corso dello studio per i pazienti affetti da IBD in trattamento con FDX, fino alla Visita 8 di fine studio (EOS) (Giorno 180) ¿registrare incidenza e gravit¿ degli eventi avversi (AE) fino alla Visita 8 EOS (Giorno 180) ¿documentare l¿impatto del trattamento sulla Qualit¿ di Vita in base alla variazione del punteggio del questionario IBDQ |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
¿ Subject is aged at least 18 ¿ Confirmed diagnosis or history of IBD for at least 3 months ¿ CDI confirmed positive according to local standard testing for the presence of C. difficile within 48 hr prior to enrolment. |
¿Soggetto di età pari o superiore a 18 anni ¿Diagnosi confermata o storia di IBD da almeno 3 mesi ¿Conferma della positività per CDI nelle 48 ore precedenti l’arruolamento confermata mediante test standard del centro per la ricerca di C. difficile.
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E.4 | Principal exclusion criteria |
¿ Subject has received more than one day of dosing of any CDI therapy within the 48 hrs prior to enrolment • Presence of an ostomy or short bowel syndrome • Subject has a current diagnosis of toxic megacolon • Subject has previously participated in a CDI vaccine study • Subject has hypersensitivity to fidaxomicin or any of its components |
¿Soggetto che ha ricevuto più di un giorno di somministrazione di qualsiasi terapia anti CDI nelle 48 ore precedenti all’arruolamento ¿Presenza di stomia oppure di sindrome da intestino corto ¿Soggetto con diagnosi di megacolon tossico attivo ¿Soggetto che ha partecipato in precedenza a uno studio sul vaccino per CDI ¿Soggetto con ipersensibilità a FDX o a qualsiasi fra i suoi componenti
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints are the pharmacokinetic parameters derived for plasma concentrations of both fidaxomicin and OP-1118. |
Gli endpoint primari sono i parametri di farmacocinetica ottenuti dalle concentrazioni plasmatiche sia di FDX che di OP-1118 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1, 5 and 10 |
Giorno 1, 5 e 10 |
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E.5.2 | Secondary end point(s) |
¿ CDI clinical response at Day 12 (TOC) ¿ microbiological response in terms of C. difficile total viable count,spore count and negative CDI toxin assay ¿ stool concentrations of fidaxomicin and its metabolite OP-1118 ¿ length of hospital stay, readmissions and resource utilization ¿ incidence and severity of AEs ¿ Short IBDQ score |
¿risposta clinica del CDI al Giorno 12 (TOC) ¿risposta microbiologica al Giorno 5 e Giorno 10 in base alla conta totale dei batteri vitali C. difficile, conta delle spore e negativit¿ al test di ricerca delle tossine da CDI ¿concentrazioni fecali di FDX e del suo metabolita OP-1118 ¿durata della degenza ospedaliera, nuovi ricoveri ospedalieri e utilizzo delle risorse nel corso dello studio fino alla Visita 8 EOS (Giorno 180) ¿incidenza e gravit¿ degli AE fino alla Visita 8 EOS (Giorno 180) ¿Punteggio del questionario Short IBDQ |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1, 5, 10, 12, 26, 40, 90 and 180 (depending on endpoint) |
Giorno 1, 5, 10, 12, 26, 40, 90 e 180 (a seconda dell'endpoint) |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
Austria |
France |
Germany |
Greece |
Italy |
Poland |
United Kingdom |
Czechia |
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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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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |