ID

13437

Beschrijving

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.

Trefwoorden

  1. 10-02-16 10-02-16 -
  2. 11-02-16 11-02-16 -
Geüploaded op

11 februari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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SacBo PZ: Case Report Form Hospitalization Information On Current Visit DRKS00000084 NCT01143272

SacBo PZ: Case Report Form Hospitalization Information On Current Visit NCT01143272

Information according to the data obtained
Beschrijving

Information according to the data obtained

What date was the patient discharged/transferred?
Beschrijving

Date of discharge/transfer

Datatype

date

Alias
UMLS CUI [1,1]
C2361123
UMLS CUI [1,2]
C0011008
UMLS CUI [2,1]
C0030704
UMLS CUI [2,2]
C0011008
What phase of the study is the patient currently in?
Beschrijving

Study phase

Datatype

integer

Alias
UMLS CUI [1]
C2348568
What date was the first dose of the initially used antibiotic applied?
Beschrijving

First dose of antibiotic

Datatype

date

Alias
UMLS CUI [1,1]
C0003232
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C0011008
What date did the first treatment phase end?
Beschrijving

End of first treatment phase (patient receives antibiotic and investigational agent)

Datatype

date

Alias
UMLS CUI [1,1]
C1710475
UMLS CUI [1,2]
C0806020
How many days of antibiotic treatment were there?
Beschrijving

Total duration of antibiotic treatment

Datatype

integer

Maateenheden
  • days
Alias
UMLS CUI [1,1]
C0444921
UMLS CUI [1,2]
C0003232
days
When did treatment phase 2 end?
Beschrijving

End of treatment phase 2 (patient receives investigational agent)

Datatype

date

Alias
UMLS CUI [1,1]
C1710475
UMLS CUI [1,2]
C0806020
When did the follow-up end?
Beschrijving

End of follow-up (6 weeks after last dose of investigational agent)

Datatype

date

Alias
UMLS CUI [1,1]
C1522577
UMLS CUI [1,2]
C0806020

Similar models

SacBo PZ: Case Report Form Hospitalization Information On Current Visit NCT01143272

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Information according to the data obtained
Date of discharge/transfer
Item
What date was the patient discharged/transferred?
date
C2361123 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0030704 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
Item
What phase of the study is the patient currently in?
integer
C2348568 (UMLS CUI [1])
Code List
What phase of the study is the patient currently in?
CL Item
Treatment Phase 1 (1)
CL Item
Treatment Phase 2 (2)
CL Item
Follow Up (3)
First dose of antibiotic
Item
What date was the first dose of the initially used antibiotic applied?
date
C0003232 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
End of first treatment phase
Item
What date did the first treatment phase end?
date
C1710475 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Total duration of antibiotic treatment
Item
How many days of antibiotic treatment were there?
integer
C0444921 (UMLS CUI [1,1])
C0003232 (UMLS CUI [1,2])
End of treatment phase 2
Item
When did treatment phase 2 end?
date
C1710475 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End of follow-up
Item
When did the follow-up end?
date
C1522577 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])

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