ID

13435

Beschrijving

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Trefwoorden

  1. 09-02-16 09-02-16 -
  2. 11-02-16 11-02-16 -
Geüploaded op

11 februari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit DRKS00000084 NCT01143272

SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit NCT01143272

Discharge/Transfer/End of study/Early study termination
Beschrijving

Discharge/Transfer/End of study/Early study termination

What date did the discharge/transferal/end of study/early study termination take place?
Beschrijving

Date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Was the patient discharges as an in-patient or did the patient revisit as an out-patient?
Beschrijving

In-patient discharge or out-patient

Datatype

boolean

Alias
UMLS CUI [1]
C0030685
UMLS CUI [2]
C0029921
Was the patient transferred to another ward or hospital?
Beschrijving

Transfer to another ward or hospital

Datatype

boolean

Alias
UMLS CUI [1]
C0030704
Did the study end regularly?
Beschrijving

End of study

Datatype

boolean

Alias
UMLS CUI [1]
C0444496
Was the study early terminated?
Beschrijving

Early study termination

Datatype

boolean

Alias
UMLS CUI [1]
C2718058
Investigational Drug Starting Box
Beschrijving

Investigational Drug Starting Box

Alias
UMLS CUI-1
C0013230
Does the patient take the starting box home?
Beschrijving

Starting box

Datatype

boolean

Investigational Drug Following Boxes
Beschrijving

Investigational Drug Following Boxes

How many days of antibiotic treatment in treatment phase 1 are there according to the data obtained?
Beschrijving

Following boxes are necessary if the antibiotic treatment in phase 1 takes longer than 10 days.

Datatype

integer

Maateenheden
  • days
Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0003232
days
How many following boxes does the patient therefore need?
Beschrijving

Therefore the patient need the following amount of following boxes

Datatype

integer

The following following boxes were already given to the patient during prior hospitalizations:
Beschrijving

Following boxes that were already given to the patient

Datatype

text

What is the number of the following box?
Beschrijving

Number of the following box

Datatype

integer

Does the patient take the following box home?
Beschrijving

Following box taken home

Datatype

boolean

Similar models

SacBo PZ: Case Report Form Hospitalization Completion Of Current Visit NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Discharge/Transfer/End of study/Early study termination
Date
Item
What date did the discharge/transferal/end of study/early study termination take place?
date
C0011008 (UMLS CUI [1])
In-patient discharge or out-patient
Item
Was the patient discharges as an in-patient or did the patient revisit as an out-patient?
boolean
C0030685 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
Transfer to another ward or hospital
Item
Was the patient transferred to another ward or hospital?
boolean
C0030704 (UMLS CUI [1])
End of study
Item
Did the study end regularly?
boolean
C0444496 (UMLS CUI [1])
Early study termination
Item
Was the study early terminated?
boolean
C2718058 (UMLS CUI [1])
Item Group
Investigational Drug Starting Box
C0013230 (UMLS CUI-1)
Starting box
Item
Does the patient take the starting box home?
boolean
Item Group
Investigational Drug Following Boxes
Duration of antibiotic treatment
Item
How many days of antibiotic treatment in treatment phase 1 are there according to the data obtained?
integer
C0444921 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Following boxes needed
Item
How many following boxes does the patient therefore need?
integer
Following boxes that were already given to the patient
Item
The following following boxes were already given to the patient during prior hospitalizations:
text
Number of the following box
Item
What is the number of the following box?
integer
Following box taken home
Item
Does the patient take the following box home?
boolean

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