ID

23180

Descripción

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

Palabras clave

Versiones (1)
  1. 26/6/17 26/6/17 -
Subido en

26 de junio de 2017

DOI

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Licencia

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

Inglés

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Age

Tipo de datos

boolean

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

Hospitalization: Critical Care Unit

Tipo de datos

boolean

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

Infection

Tipo de datos

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
Descripción

Antibiotics

Tipo de datos

boolean

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

Administration Route

Tipo de datos

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.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Descripción

Control Group

Tipo de datos

boolean

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

Prophylactic antibiotics

Tipo de datos

boolean

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

Hospital Stay

Tipo de datos

boolean

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

Time of Administration

Tipo de datos

boolean

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

Single Dose

Tipo de datos

boolean

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

Withdrawal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2349954
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Similar models

Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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