0 Ratings
ID

13423

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 (3)
  1. 2/4/16 2/4/16 -
  2. 2/11/16 2/11/16 -
  3. 2/11/16 2/11/16 -
Uploaded on

February 11, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    SacBo TI: Case Report Form Phone Interview Medication Obligatory For Documentation DRKS00000084 NCT01143272

    English

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

    1 forms  
    Antibiotic treatment
    Description

    Antibiotic treatment

    What is the number of this line?
    Description

    Line

    Data type

    integer

    Whats is the name of the antibiotic used?
    Description

    name of the antibiotic used

    Data type

    text

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

    antibiotic class

    Data type

    integer

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

    First dose

    Data type

    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?
    Description

    Entire day dose at first dose

    Data type

    boolean

    What date was the last dose given?
    Description

    last dose

    Data type

    date

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

    duration (days)

    Data type

    integer

    Measurement units
    • days
    Alias
    UMLS CUI [1]
    C0449238
    days
    When did the antibiotic treatment end?
    Description

    end of antibiotic treatment

    Data type

    text

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

    Treatment with drugs/opiates causing constipation

    What is the number of this line?
    Description

    line

    Data type

    integer

    What is the name of the medication?
    Description

    medication name

    Data type

    text

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

    first dose

    Data type

    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?
    Description

    Date of first dose unknown

    Data type

    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?
    Description

    Date of last dose

    Data type

    date

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

    Date of last dose unknown

    Data type

    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
    Description

    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?
    Description

    Line

    Data type

    integer

    What is the name of the medication used?
    Description

    medication name

    Data type

    text

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

    first dose

    Data type

    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?
    Description

    Date of first dose unknown

    Data type

    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?
    Description

    Date of last dose

    Data type

    date

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

    Date of last dose unknown

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1762893
    UMLS CUI [1,2]
    C0439673
    Back to the top of the page

    Similar models

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

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Back to the top of the page 

    Help

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial