ID

13423

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

Versies (3)
  1. 04-02-16 04-02-16 -
  2. 11-02-16 11-02-16 -
  3. 11-02-16 11-02-16 -
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11 februari 2016

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Creative Commons BY-NC 3.0
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SacBo TI: Case Report Form Phone Interview Medication Obligatory For Documentation DRKS00000084 NCT01143272

Engels

SacBo TI: Case Report Form Phone Interview Medication Obligatory For Documentation NCT01143272

1 Formulieren  
Antibiotic treatment
Beschrijving

Antibiotic treatment

What is the number of this line?
Beschrijving

Line

Datatype

integer

Whats is the name of the antibiotic used?
Beschrijving

name of the antibiotic used

Datatype

text

Alias
UMLS CUI [1]
C2360065
What class does the antibiotic used belong to?
Beschrijving

antibiotic class

Datatype

integer

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C1515021
What date was the first dose applied?
Beschrijving

First dose

Datatype

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
Was an entire day dose given at first dose?
Beschrijving

Entire day dose at first dose

Datatype

boolean

What date was the last dose given?
Beschrijving

last dose

Datatype

date

Alias
UMLS CUI [1]
C1762893
How many days was the patient treated with the antibiotic?
Beschrijving

duration (days)

Datatype

integer

Maateenheden
  • days
Alias
UMLS CUI [1]
C0449238
days
When did the antibiotic treatment end?
Beschrijving

end of antibiotic treatment

Datatype

text

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0003232
Treatment with drugs/opiates causing constipation
Beschrijving

Treatment with drugs/opiates causing constipation

What is the number of this line?
Beschrijving

line

Datatype

integer

What is the name of the medication?
Beschrijving

medication name

Datatype

text

Alias
UMLS CUI [1]
C2360065
When did the treatment with this medication start?
Beschrijving

first dose

Datatype

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
Is the date the medication was first applied not known?
Beschrijving

Date of first dose unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0439673
UMLS CUI [1,4]
C0011008
When was the last dose of this medication applied?
Beschrijving

Date of last dose

Datatype

date

Alias
UMLS CUI [1]
C1762893
Is the date of the last dose not known?
Beschrijving

Date of last dose unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0439673
Treatment with systemic antifungal agents; note that the use of systemic antifungal agents makes the patient retrospectively ineligible for this study as of exclusion criterion 06; please record early study termination if this is the case
Beschrijving

Treatment with systemic antifungal agents; note that the use of systemic antifungal agents makes the patient retrospectively ineligible for this study as of exclusion criterion 06; please record early study termination if this is the case

What is the number of this line?
Beschrijving

Line

Datatype

integer

What is the name of the medication used?
Beschrijving

medication name

Datatype

text

Alias
UMLS CUI [1]
C2360065
When did the treatment with this medication start?
Beschrijving

first dose

Datatype

date

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
Is the date the medication was first applied not known?
Beschrijving

Date of first dose unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0439673
UMLS CUI [1,4]
C0011008
When was the last dose of this medication applied?
Beschrijving

Date of last dose

Datatype

date

Alias
UMLS CUI [1]
C1762893
Is the date of the last dose not known?
Beschrijving

Date of last dose unknown

Datatype

boolean

Alias
UMLS CUI [1,1]
C1762893
UMLS CUI [1,2]
C0439673
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Similar models

SacBo TI: Case Report Form Phone Interview Medication Obligatory For Documentation NCT01143272

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Antibiotic treatment
line
Item
What is the number of this line?
integer
medication name
Item
Whats is the name of the antibiotic used?
text
C2360065 (UMLS CUI [1])
Item
What class does the antibiotic used belong to?
integer
C0003232 (UMLS CUI [1,1])
C1515021 (UMLS CUI [1,2])
class of antibiotic
Code List
What class does the antibiotic used belong to?
CL Item
beta-lactam (1)
CL Item
Tetracycline (2)
CL Item
Aminoglycoside (3)
CL Item
Macrolide (4)
CL Item
Lincosamid (5)
CL Item
Gyrase-Inhibitor (6)
CL Item
Sulfonamide/Trimethoprim (7)
CL Item
Glycopeptide (8)
CL Item
Polypeptide (9)
CL Item
Nitroimidazol derivate (10)
CL Item
unknown (11)
First dose
Item
What date was the first dose applied?
date
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Entire day dose at first dose
Item
Was an entire day dose given at first dose?
boolean
last dose
Item
What date was the last dose given?
date
C1762893 (UMLS CUI [1])
duration
Item
How many days was the patient treated with the antibiotic?
integer
C0449238 (UMLS CUI [1])
end of antibiotic treatment
Item
When did the antibiotic treatment end?
text
C0806020 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
Item Group
Treatment with drugs/opiates causing constipation
line
Item
What is the number of this line?
integer
medication name
Item
What is the name of the medication?
text
C2360065 (UMLS CUI [1])
first dose
Item
When did the treatment with this medication start?
date
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of first dose unknown
Item
Is the date the medication was first applied not known?
boolean
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Date of last dose
Item
When was the last dose of this medication applied?
date
C1762893 (UMLS CUI [1])
Date of last dose unknown
Item
Is the date of the last dose not known?
boolean
C1762893 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item Group
Treatment with systemic antifungal agents; note that the use of systemic antifungal agents makes the patient retrospectively ineligible for this study as of exclusion criterion 06; please record early study termination if this is the case
Line
Item
What is the number of this line?
integer
medication name
Item
What is the name of the medication used?
text
C2360065 (UMLS CUI [1])
first dose
Item
When did the treatment with this medication start?
date
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Date of first dose unknown
Item
Is the date the medication was first applied not known?
boolean
C3174092 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Date of last dose
Item
When was the last dose of this medication applied?
date
C1762893 (UMLS CUI [1])
Date of last dose unknown
Item
Is the date of the last dose not known?
boolean
C1762893 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
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