ID

13431

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. 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.

Trefwoorden

  1. 08-02-16 08-02-16 -
  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 Medication subject to documentation DRKS00000084 NCT01143272

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

Antibiotics
Beschrijving

Antibiotics

Alias
UMLS CUI-1
C0003232
Number
Beschrijving

Number

Datatype

text

Antibiotic group
Beschrijving

Antibiotic group

Datatype

integer

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

Indication AAD-CDAD

Datatype

integer

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

Indication: ICD-10-Code Antibiotic

Datatype

text

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

Application of antibiotic

Datatype

integer

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

First dose

Datatype

date

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

Date of the last dose

Datatype

date

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

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

Datatype

boolean

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

According to the data obtained: End of treatment phase 1

Datatype

date

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

Further medication subject to documentation

Whats is the number of the medication?
Beschrijving

Number of medication

Datatype

text

What kind of medication was used?
Beschrijving

Medication

Datatype

integer

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

First dose

Datatype

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?
Beschrijving

Last dose

Datatype

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)
Datatype
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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