ID

13439

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

  1. 2/10/16 2/10/16 -
  2. 2/10/16 2/10/16 - Julian Varghese
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 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 Early Study Termination DRKS00000084 NCT01143272

SacBo PZ: Case Report Form AE Termination Signature Early Study Termination NCT01143272

Early study termination
Description

Early study termination

Alias
UMLS CUI-1
C2718058
When was the study terminated?
Description

Date of early study termination

Data type

date

Alias
UMLS CUI [1,1]
C2718058
UMLS CUI [1,2]
C0011008
Was the reason for early study termination the repeal of consent?
Description

Repeal of consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Did the patient become retrospectively ineligible by failing to meet the inclusion/exclusion criteria and if so what criterion was the reason for becoming ineligible?
Description

Retrospectively ineligible

Data type

text

Alias
UMLS CUI [1]
C1516637
Does the patient receive a central venous catheter?
Description

Central venous catheter

Data type

boolean

Alias
UMLS CUI [1]
C1145640
Did any kind of immunosuppression occur?
Description

Immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0021079
Was the study early terminated by the doctor due to hypersensitivity reaction or any other severe complications?
Description

Termination by the doctor due to hypersensitivity reaction (see also professional information, attachment 2 section 4.8) or any other severe complications

Data type

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C0009566
Comment:
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Is there any other reason for early study termination?
Description

Any other reason for early study termination

Data type

boolean

Alias
UMLS CUI [1]
C2718058
Comment:
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611

Similar models

SacBo PZ: Case Report Form AE Termination Signature Early Study Termination NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Early study termination
C2718058 (UMLS CUI-1)
Date of early study termination
Item
When was the study terminated?
date
C2718058 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Repeal of consent
Item
Was the reason for early study termination the repeal of consent?
boolean
C0021430 (UMLS CUI [1])
Item
Did the patient become retrospectively ineligible by failing to meet the inclusion/exclusion criteria and if so what criterion was the reason for becoming ineligible?
text
C1516637 (UMLS CUI [1])
Code List
Did the patient become retrospectively ineligible by failing to meet the inclusion/exclusion criteria and if so what criterion was the reason for becoming ineligible?
CL Item
Adult (Inclusion1 )
CL Item
Patient physically and mentally fit (Inclusion5 )
CL Item
Patient hospitalized in study hospital (Inclusion2 )
CL Item
systemic antiobiotic treatment planned (>= 3 days) (Inclusion3 )
CL Item
Patient contractually capable (Inclusion4 )
CL Item
For women of child-bearing age: contraception (Inclusion6 )
CL Item
Informed consent obtained (Inclusion7 )
CL Item
Hypersensitivity to yeast and/or perenterol (Exclusion1 )
CL Item
Central venous catheterization (Exclusion2 )
CL Item
Immunosuppression (Exclusion3 )
CL Item
Currently having diarrhea and/or frequent diarrhea (Exclusion4 )
CL Item
Frequent use of perenterol or yomogi (7 days before start of study) (Exclusion5 )
CL Item
systemic antifungal treatment (Exclusion6 )
CL Item
systemic antibiotic treatment (6 weeks before start of study) (Exclusion7 )
CL Item
for women: pregnancy (Exclusion8 )
CL Item
for women: lactation (Exclusion9 )
CL Item
currently participating in another trial (Exclusion10 )
Central venous catheter
Item
Does the patient receive a central venous catheter?
boolean
C1145640 (UMLS CUI [1])
Immunosuppression
Item
Did any kind of immunosuppression occur?
boolean
C0021079 (UMLS CUI [1])
Termination by the doctor
Item
Was the study early terminated by the doctor due to hypersensitivity reaction or any other severe complications?
boolean
C0020517 (UMLS CUI [1])
C0009566 (UMLS CUI [2])
Comment
Item
Comment:
text
C0947611 (UMLS CUI [1])
Any other reason for early study termination
Item
Is there any other reason for early study termination?
boolean
C2718058 (UMLS CUI [1])
Comment
Item
Comment:
text
C0947611 (UMLS CUI [1])

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