E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibiotic - associated - Diarrhoea (AAD) Clostridium difficile - associated - Diarrhoea (CDAD) |
Antibiotika-assoziierte Diarrhö (AAD) Clostridium difficile-assoziierte Diarrhö (CDAD) |
|
E.1.1.1 | Medical condition in easily understood language |
Antibiotic-associated diarrhoea and Clostridium difficile-associated diarrhoea are frequent and severe, possibly even life-threatening conditions in patients receiving antibiotic treatment. |
Antibiotika-assoziierte Diarrhö und Clostridium difficile-assoziierte Diarrhö sind häufige und potentiell lebensbedrohliche Komplikationen bei Patienten unter antibiotischer Therapie. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012748 |
E.1.2 | Term | Diarrhoea, Clostridium difficile |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10006835 |
E.1.2 | Term | C.difficile diarrhoea |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055956 |
E.1.2 | Term | Antibiotic-associated diarrhoea |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 |
Evaluation of the efficacy of Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea in hospitalized, adult patients. |
Evaluierung der Wirksamkeit von Saccharomyces boulardii zur Prävention einer AAD bei hospitalisierten, erwachsenen Patienten. |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of the efficacy of Saccharomyces boulardii for the prevention of Clostridium difficile-associated diarrhoea in hospitalized, adult patients. |
Evaluierung der Wirksamkeit von Saccharomyces boulardii zur Prävention einer CDAD bei hospitalisierten, erwachsenen Patienten. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult, hospitalized patients receiving systemic antibiotic treatment Written informed consent Participant is not participating in any other clinical trial |
Erwachsene, hospitalisierte Patienten unter systemischer antibiotischer Therapie Unterschriebene Einwilligungserklärung Studienteilnehmer nimmt nicht gleichzeitig an anderen klinischen Studien teil |
|
E.4 | Principal exclusion criteria |
Allergy against Saccharomyces boulardii Central venous catheter Immunosuppression Chronic diarrhoea Regular intake of Saccharomyces boulardii before beginning of the study Systemic antimycotic treatment Systemic antibiotic treatment within the last 6 weeks Pregnancy
|
Allergie gegen Saccharomyces boulardii Zentraler Venenkatheter Immunsuppression Chronische Diarrhö Regelmäßige Einnahme von Saccharomyces boulardii vor Studienbeginn Systemische antimykotische Behandlung Systemische antibiotische Behandlung innerhalb der letzten 6 Wochen Schwangerschaft
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative incidence of any antibiotic-associated diarrhoea |
kumulative Inzidenz der Antibiotika-assoziierten Diarrhö
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Ende der Studie |
|
E.5.2 | Secondary end point(s) |
Cumulative incidence of any Clostridium difficile-associated diarrhoea (CDAD), Cumulative incidence of any AAD without evidence of CDAD, AAD and CDAD, Incidence of any AAD in dependency from initial white blood cell count and CRP, Densitiy of incidence of any AAD and CDAD, Average Duration of any of any AAD and CDAD, Average stool frequency at AAD and CDAD, Cumulative incidence of stopping and changing the initially applied antibiotic treatment
|
kumulative Inzidenz einer Clostridium difficile-assoziierten Diarrhö (CDAD), kumulative Inzidenz einer AAD ohne Nachweis einer CDAD, kumulative Inzidenz einer CDAD unter allen AAD-Patienten, Auftreten einer AAD in Abhängigkeit von initialer Leukozytenzahl und CRP, Auftreten einer CDAD in Abhängigkeit von initialer Leukozytenzahl und CRP, Inzidenzdichte einer AAD bzw. CDAD, mittlere Dauer einer AAD bzw. CDAD, mittlere Stuhlfrequenz unter einer AAD bzw. CDAD, kumulative Inzidenz des Absetzens oder Wechsels des initial verabreichten Antibiotikums
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of the study |
Ende der Studie |
|
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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
| 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 | 11 |
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 | 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
|
Last patient completed follow-up. |
Abschluss des Follow-up des letzten Patienten |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
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 |