ID

13431

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. Please note: 1) At first hospitalization please enter the antibiotic initially used in the first line! 2) Please enter the medication in chronological order! 3) Obligatory documentation starts with the date the (re-) hospitalization begins! If there is preexisting medication the starting date is determined as follows: a) First hospitalization = Date of first dose of antibiotic! b) Rehospitalization = Date of Rehospitalization! 4) Documentation of the last dose of any of the medication subject for documentation is only necessary until the regular end of the study.

Mots-clés

  1. 08/02/2016 08/02/2016 -
  2. 11/02/2016 11/02/2016 -
Téléchargé le

11 février 2016

DOI

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Licence

Creative Commons BY-NC 3.0

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    SacBo PZ: Case Report Form Hospitalization Medication subject to documentation DRKS00000084 NCT01143272

    SacBo PZ: Case Report Form Hospitalization Medication subject to documentation NCT01143272

    Antibiotics
    Description

    Antibiotics

    Alias
    UMLS CUI-1
    C0003232
    Number
    Description

    Number

    Type de données

    text

    Antibiotic group
    Description

    Antibiotic group

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0003232
    UMLS CUI [1,2]
    C1515021
    What was the indication for the treatment?
    Description

    Indication AAD-CDAD

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0578159
    UMLS CUI [2]
    C0235952
    What is the ICD-10 code of the indication?
    Description

    Indication: ICD-10-Code Antibiotic

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1137110
    How was the antibiotic applied?
    Description

    Application of antibiotic

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0278296
    When was the first dose applied?
    Description

    First dose

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205435
    UMLS CUI [1,3]
    C0011008
    When was the last dose applied?
    Description

    Date of the last dose

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1762893
    If antibiotic was used: was the treatment terminated because of AAD/CDAD?
    Description

    If antibiotic was used: was the treatment terminated because of AAD/CDAD?

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0871548
    When did treatment phase 1 end?
    Description

    According to the data obtained: End of treatment phase 1

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C2348563
    UMLS CUI [1,2]
    C0011008
    Further medication subject to documentation
    Description

    Further medication subject to documentation

    Whats is the number of the medication?
    Description

    Number of medication

    Type de données

    text

    What kind of medication was used?
    Description

    Medication

    Type de données

    integer

    Alias
    UMLS CUI [1]
    C0013227
    When was the first dose of the medication used?
    Description

    First dose

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205435
    UMLS CUI [1,3]
    C0011008
    When was the last dose of the medication used?
    Description

    Last dose

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1762893

    Similar models

    SacBo PZ: Case Report Form Hospitalization Medication subject to documentation NCT01143272

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Antibiotics
    C0003232 (UMLS CUI-1)
    Number
    Item
    Number
    text
    Item
    Antibiotic group
    integer
    C0003232 (UMLS CUI [1,1])
    C1515021 (UMLS CUI [1,2])
    Code List
    Antibiotic group
    CL Item
    Beta-Lactam (1)
    CL Item
    Tetracycline (2)
    CL Item
    Aminoglycoside (3)
    CL Item
    Macrolide (4)
    CL Item
    Lincosamide (5)
    CL Item
    Gyrase inhibitor (6)
    CL Item
    Sulfonamide (7)
    CL Item
    Glykopeptide (8)
    CL Item
    Polypeptide (9)
    CL Item
    Nitroimidazole Derivative (10)
    Item
    What was the indication for the treatment?
    integer
    C0578159 (UMLS CUI [1])
    C0235952 (UMLS CUI [2])
    Code List
    What was the indication for the treatment?
    CL Item
    Antibiotic-associated diarrhea (1)
    CL Item
    Clostridium difficile associated diarrhea (2)
    Indication: ICD-10-Code Antibiotic
    Item
    What is the ICD-10 code of the indication?
    text
    C1137110 (UMLS CUI [1])
    Item
    How was the antibiotic applied?
    integer
    C0278296 (UMLS CUI [1])
    Code List
    How was the antibiotic applied?
    CL Item
    oral (1)
    CL Item
    intravenous (2)
    CL Item
    intramuscular (3)
    First dose
    Item
    When was the first dose applied?
    date
    C3174092 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Last dose
    Item
    When was the last dose applied?
    date
    C1762893 (UMLS CUI [1])
    Treatment termination because of AAD/CDAD
    Item
    If antibiotic was used: was the treatment terminated because of AAD/CDAD?
    boolean
    C0871548 (UMLS CUI [1])
    End of treatment phase 1
    Item
    When did treatment phase 1 end?
    date
    C2348563 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item Group
    Further medication subject to documentation
    Number of medication
    Item
    Whats is the number of the medication?
    text
    Item
    What kind of medication was used?
    integer
    C0013227 (UMLS CUI [1])
    Code List
    What kind of medication was used?
    CL Item
    Laxatives (1)
    CL Item
    Opiates causing obstipation / other medication causing obstipation (2)
    CL Item
    systemic antifungal agents (3)
    First dose
    Item
    When was the first dose of the medication used?
    date
    C3174092 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Last dose
    Item
    When was the last dose of the medication used?
    date
    C1762893 (UMLS CUI [1])

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