ID

13423

Descrizione

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

versioni (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 febbraio 2016

DOI

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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

Inglese

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

1 moduli  
Antibiotic treatment
Descrizione

Antibiotic treatment

What is the number of this line?
Descrizione

Line

Tipo di dati

integer

Whats is the name of the antibiotic used?
Descrizione

name of the antibiotic used

Tipo di dati

text

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

antibiotic class

Tipo di dati

integer

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

First dose

Tipo di dati

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?
Descrizione

Entire day dose at first dose

Tipo di dati

boolean

What date was the last dose given?
Descrizione

last dose

Tipo di dati

date

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

duration (days)

Tipo di dati

integer

Unità di misura
  • days
Alias
UMLS CUI [1]
C0449238
days
When did the antibiotic treatment end?
Descrizione

end of antibiotic treatment

Tipo di dati

text

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

Treatment with drugs/opiates causing constipation

What is the number of this line?
Descrizione

line

Tipo di dati

integer

What is the name of the medication?
Descrizione

medication name

Tipo di dati

text

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

first dose

Tipo di dati

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?
Descrizione

Date of first dose unknown

Tipo di dati

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?
Descrizione

Date of last dose

Tipo di dati

date

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

Date of last dose unknown

Tipo di dati

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
Descrizione

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?
Descrizione

Line

Tipo di dati

integer

What is the name of the medication used?
Descrizione

medication name

Tipo di dati

text

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

first dose

Tipo di dati

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?
Descrizione

Date of first dose unknown

Tipo di dati

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?
Descrizione

Date of last dose

Tipo di dati

date

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

Date of last dose unknown

Tipo di dati

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 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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