ID

13436

Beschreibung

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.

Stichworte

  1. 10.02.16 10.02.16 -
  2. 10.02.16 10.02.16 - Julian Varghese
  3. 11.02.16 11.02.16 -
Hochgeladen am

11. Februar 2016

DOI

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Lizenz

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
Beschreibung

Doctor's letter received after transferal

Was the discharge document received after transferal?
Beschreibung

Discharge document received after transferal

Datentyp

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?
Beschreibung

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

Datentyp

date

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

New episode of antibiotic associated diarrhea

Datentyp

boolean

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

New episode of clostridium difficile associated diarrhea

Datentyp

boolean

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

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

Datentyp

boolean

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

Medication subject to documentation

What is the number of the medication?
Beschreibung

Number of medication

Datentyp

integer

What kind of medication was used?
Beschreibung

Medication

Datentyp

integer

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

First dose

Datentyp

date

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

Last dose

Datentyp

date

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

Doctor's letter after transferal not received despite request

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

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

Datentyp

boolean

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

Ähnliche Modelle

SacBo PZ: Case Report Form Hospitalization Transferal NCT01143272

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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