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ID

13436

Beskrivning

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.

Nyckelord

  1. 2016-02-10 2016-02-10 -
  2. 2016-02-10 2016-02-10 - Julian Varghese
  3. 2016-02-11 2016-02-11 -
Uppladdad den

11 februari 2016

DOI

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Creative Commons BY-NC 3.0

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    SacBo PZ: Case Report Form Hospitalization Transferal DRKS00000084 NCT01143272

    SacBo PZ: Case Report Form Hospitalization Transferal NCT01143272

    Doctor's letter received after transferal
    Beskrivning

    Doctor's letter received after transferal

    Was the discharge document received after transferal?
    Beskrivning

    Discharge document received after transferal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030685
    UMLS CUI [1,2]
    C0684224
    What date was the patient discharged from the ward/hospital where the treatment was continued?
    Beskrivning

    If the doctor's letter was received after transferal please enter the date the patient was discharged from the ward/hospital where the treatment was continued

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C2361123
    Was there a new episode of AAD after the transferal to a different ward/hospital?
    Beskrivning

    New episode of antibiotic associated diarrhea

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0578159
    Was there a new episode of clostridium difficile associated diarrhea after transferal to a different ward/hospital?
    Beskrivning

    New episode of clostridium difficile associated diarrhea

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0235952
    Was the study terminated early?
    Beskrivning

    Early study termination (if yes, please note under early study termination)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2718058
    Medication subject to documentation
    Beskrivning

    Medication subject to documentation

    What is the number of the medication?
    Beskrivning

    Number of medication

    Datatyp

    integer

    What kind of medication was used?
    Beskrivning

    Medication

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C0013227
    What date was the first dose used?
    Beskrivning

    First dose

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0205435
    What date was the last dose used?
    Beskrivning

    Last dose

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1762893
    Doctor's letter after transferal not received despite request
    Beskrivning

    Doctor's letter after transferal not received despite request

    Was the doctor's letter after transferal not received despite request?
    Beskrivning

    Doctor's letter after transferal not received despite request. Study documentation could therefore only be performed until the day of transferal

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030685
    UMLS CUI [1,2]
    C0684224

    Similar models

    SacBo PZ: Case Report Form Hospitalization Transferal NCT01143272

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Doctor's letter received after transferal
    discharge document received after transferal
    Item
    Was the discharge document received after transferal?
    boolean
    C0030685 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])
    Date of discharge
    Item
    What date was the patient discharged from the ward/hospital where the treatment was continued?
    date
    C2361123 (UMLS CUI [1])
    New episode of antibiotic associated diarrhea
    Item
    Was there a new episode of AAD after the transferal to a different ward/hospital?
    boolean
    C0578159 (UMLS CUI [1])
    New episode of clostridium difficile associated diarrhea
    Item
    Was there a new episode of clostridium difficile associated diarrhea after transferal to a different ward/hospital?
    boolean
    C0235952 (UMLS CUI [1])
    Early study termination
    Item
    Was the study terminated early?
    boolean
    C2718058 (UMLS CUI [1])
    Item Group
    Medication subject to documentation
    Number of medication
    Item
    What is the number of the medication?
    integer
    Item
    What kind of medication was used?
    integer
    C0013227 (UMLS CUI [1])
    Code List
    What kind of medication was used?
    CL Item
    Beta-Lactam Antibiotic  (1)
    CL Item
    Tetracycline  (2)
    CL Item
    Aminoglycoside  (3)
    CL Item
    Macrolide Antibiotic  (4)
    CL Item
    Lincosamide  (5)
    CL Item
    Gyrase inhibitor  (6)
    CL Item
    Sulfonamide/Trimethoprim  (7)
    CL Item
    Glykopeptide Antibiotic  (8)
    CL Item
    Polypeptide Antibiotic  (9)
    CL Item
    Nitroimidazole Derivative  (10)
    CL Item
    Laxatives  (11)
    CL Item
    Opiates causing obstipation / other medication causing obstipation  (12)
    CL Item
    Systemic antifungal agents (13)
    First dose
    Item
    What date was the first dose used?
    date
    C3174092 (UMLS CUI [1,1])
    C0205435 (UMLS CUI [1,2])
    Last dose
    Item
    What date was the last dose used?
    date
    C1762893 (UMLS CUI [1])
    Item Group
    Doctor's letter after transferal not received despite request
    Doctor's letter after transferal not received despite request
    Item
    Was the doctor's letter after transferal not received despite request?
    boolean
    C0030685 (UMLS CUI [1,1])
    C0684224 (UMLS CUI [1,2])

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