ID

23180

Description

Responsible Party: Michael Zoller MD, senior physician, Ludwig-Maximilians - University of Munich ClinicalTrials.gov Identifier: NCT01793012 History of Changes Other Study ID Numbers: MUC 428-12 DRKS00004426 ( Other Identifier: German clinical trials register ) Study First Received: January 24, 2013 Last Updated: March 30, 2015 Drug Monitoring of Antibiotics in Critical Care Patients (DRAK) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01793012

Link

https://clinicaltrials.gov/ct2/show/NCT01793012

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Antibiotics in Critical Care Patients DRKS00004426 NCT01793012 DRKS00004426

English

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
0. 18 Years and older (Adult, Senior)
Description

Age

Data type

boolean

1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Description

Hospitalization: Critical Care Unit

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0021708
2. Presence of infection by clinical assessment
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Description

Antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C0003232
4. Bolus administration of selected antibiotics
Description

Administration Route

Data type

boolean

Alias
UMLS CUI [1]
C0013153
5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
1. Prophylactic antibiotics without clinical assessment for the presence of infection
Description

Prophylactic antibiotics

Data type

boolean

Alias
UMLS CUI [1]
C1388076
2. Planned shorter hospital stay than 4 days
Description

Hospital Stay

Data type

boolean

Alias
UMLS CUI [1]
C3489408
3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
Description

Time of Administration

Data type

boolean

Alias
UMLS CUI [1]
C1317775
4. Only a single dose of an antibiotic per day
Description

Single Dose

Data type

boolean

Alias
UMLS CUI [1]
C1960417
5. Subsequent withdrawal of the participation in the study by the patient or the guardian
Description

Withdrawal

Data type

boolean

Alias
UMLS CUI [1]
C2349954
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Similar models

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
0. 18 Years and older (Adult, Senior)
boolean
Hospitalization: Critical Care Unit
Item
1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
boolean
C0019993 (UMLS CUI [1,1])
C0021708 (UMLS CUI [1,2])
Infection
Item
2. Presence of infection by clinical assessment
boolean
C0009450 (UMLS CUI [1])
Antibiotics
Item
3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
boolean
C0003232 (UMLS CUI [1])
Administration Route
Item
4. Bolus administration of selected antibiotics
boolean
C0013153 (UMLS CUI [1])
Informed Consent
Item
5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
0. Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Prophylactic antibiotics
Item
1. Prophylactic antibiotics without clinical assessment for the presence of infection
boolean
C1388076 (UMLS CUI [1])
Hospital Stay
Item
2. Planned shorter hospital stay than 4 days
boolean
C3489408 (UMLS CUI [1])
Time of Administration
Item
3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
boolean
C1317775 (UMLS CUI [1])
Single Dose
Item
4. Only a single dose of an antibiotic per day
boolean
C1960417 (UMLS CUI [1])
Withdrawal
Item
5. Subsequent withdrawal of the participation in the study by the patient or the guardian
boolean
C2349954 (UMLS CUI [1])
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