ID

13542

Description

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.

Keywords

Versions (1)
  1. 2/15/16 2/15/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

February 15, 2016

DOI

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License

Creative Commons BY-NC 3.0
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SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272

English

SacBo PZ: Case Report Form AE Termination Signature AE NCT01143272

1 forms  
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Adverse event number
Description

Adverse event number

Data type

integer

Alias
UMLS CUI [1]
C0877248
Adverse event:
Description

Adverse event

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event starting date
Description

Adverse event starting date

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0808070
Severe adverse event?
Description

Severe adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0205082
Measures taken regarding investigational agent
Description

Measures taken regarding investigational agent

Data type

integer

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0079809
Does the adverse event lead to study termination?
Description

Adverse event leads to study termination

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348581
Connection between adverse event and investigational agent
Description

Connection between adverse event and investigational agent

Data type

integer

Alias
UMLS CUI [1,1]
C1875319
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0449379
intensitiy of the adverse event
Description

intensitiy of the adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0522510
UMLS CUI [1,2]
C0877248
end date of adverse event
Description

end date of adverse event

Data type

date

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0806020
Adverse event still ongoing at transferal
Description

Adverse event still ongoing at transferal

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0030704
UMLS CUI [1,3]
C0549178
Outcome of the adverse event
Description

Outcome of the adverse event

Data type

integer

Alias
UMLS CUI [1]
C1705586
Any further adverse event subject to documentation
Description

Any further adverse event subject to documentation

Data type

boolean

Alias
UMLS CUI [1]
C0877248
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Similar models

SacBo PZ: Case Report Form AE Termination Signature AE NCT01143272

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Adverse event number
Item
Adverse event number
integer
C0877248 (UMLS CUI [1])
Adverse event
Item
Adverse event:
text
C0877248 (UMLS CUI [1])
Adverse event starting date
Item
Adverse event starting date
date
C0877248 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Severe adverse event?
integer
C0877248 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Severe adverse event
Code List
Severe adverse event?
CL Item
Yes, severe adverse event documented (1)
CL Item
Yes, but due to protocol 10.2 no severe adverse event documentation necessary (2)
CL Item
No (3)
Item
Measures taken regarding investigational agent
integer
C0013227 (UMLS CUI [1,1])
C0079809 (UMLS CUI [1,2])
Measures taken regarding investigational agent
Code List
Measures taken regarding investigational agent
CL Item
No change of dose (1)
CL Item
Medication momentarily stopped (2)
CL Item
Medication definitely stopped (3)
CL Item
Unknown (4)
CL Item
Not applicable (5)
Adverse event leads to study termination
Item
Does the adverse event lead to study termination?
boolean
C0877248 (UMLS CUI [1,1])
C2348581 (UMLS CUI [1,2])
Item
Connection between adverse event and investigational agent
integer
C1875319 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0449379 (UMLS CUI [1,3])
Connection between adverse event and investigational agent
Code List
Connection between adverse event and investigational agent
CL Item
no suspicion of there being a connection between adverse event and investigational agent (1)
CL Item
suspicion of there being a connection between adverse event and investigational agent (2)
Item
intensitiy of the adverse event
integer
C0522510 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
intensity
Code List
intensitiy of the adverse event
CL Item
light (activities of daily living are not affected) (1)
CL Item
medium (activities of daily living are affected) (2)
CL Item
severe (activities of daily living or work is impossible) (3)
end date of adverse event
Item
end date of adverse event
date
C0877248 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Adverse event still ongoing at transferal
Item
Adverse event still ongoing at transferal
boolean
C0877248 (UMLS CUI [1,1])
C0030704 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Outcome of the adverse event
integer
C1705586 (UMLS CUI [1])
Outcome of the adverse event
Code List
Outcome of the adverse event
CL Item
restored (1)
CL Item
improved (2)
CL Item
not improved yet (3)
CL Item
restored with damage (4)
CL Item
unknown (5)
CL Item
death (6)
Any further adverse event subject to documentation
Item
Any further adverse event subject to documentation
boolean
C0877248 (UMLS CUI [1])
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