ID

12175

Beskrivning

A Study of Caspofungin, Liposomal Amphotericin B or the Combination of Both for Patients After Stem-Cell Transplantation NCT00148148

Nyckelord

Versioner (2)
  1. 2015-10-06 2015-10-06 -
  2. 2015-10-06 2015-10-06 - Martin Dugas
Uppladdad den

6 oktober 2015

DOI

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Creative Commons BY-NC 3.0 Legacy
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Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

Tysk Engelsk

Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

1 Formulär  
Inclusion criteria
Beskrivning

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Adult Patient (>=18 years) with granulocytopenia (absolute number neutrophil: <=500 / ul) and allogeneic hematopoietic condition after Stem cell transplantation and immunosuppression with cyclosporine A
Beskrivning

Adult Patient (≥ 18 years) with granulocytopenia (absolute number neutrophil: ≤500 / μl) and allogeneic hematopoietic condition after Stem cell transplantation and immunosuppression with cyclosporine A

Datatyp

boolean

Patient with persistent or relapsed fever (oral temperature ≥38.0°C) and granulocytopenia (absolute Neutrophil Count ≤500 / μl) and adequate antibacterial therapy for ≥36-48 Hours in need of empirical antifungal therapy A
Beskrivning

Patient with persistent or relapsed fever (oral temperature ≥38.0°C) and granulocytopenia (absolute Neutrophil Count ≤500 / μl) and adequate antibacterial therapy for ≥36-48 Hours in need of empirical antifungal therapy A

Datatyp

boolean

Reclining, at least double-recurrent central venous catheters for administration of drugs and for the extraction of plasma samples
Beskrivning

Reclining, at least double-recurrent central venous catheters for administration of drugs and for the extraction of plasma samples

Datatyp

boolean

For patients of childbearing age: existence of a negative Pregnancy tests within 7 days prior to initiation of treatment and adequate contraception during study participation
Beskrivning

For patients of childbearing age: existence of a negative Pregnancy tests within 7 days prior to initiation of treatment and adequate contraception during study participation

Datatyp

boolean

Life expectancy ≥5 days
Beskrivning

Life expectancy ≥5 days

Datatyp

boolean

Treatment in one of said test centers
Beskrivning

Treatment in one of said test centers

Datatyp

boolean

Adequate renal and hepatic function in accordance with the following definitions
Beskrivning

Adequate renal and hepatic function in accordance with the following definitions

Datatyp

boolean

Bilirubin Total: ≤ 3x upper reference value
Beskrivning

Bilirubin Total: ≤ 3x upper reference value

Datatyp

boolean

SGOT or SGPT: ≤ 3x upper reference value
Beskrivning

SGOT or SGPT: ≤ 3x upper reference value

Datatyp

boolean

Alkaline phosphatase: ≤ 5x upper reference value
Beskrivning

Alkaline phosphatase: ≤ 5x upper reference value

Datatyp

boolean

Creatinine i. S.: ≤ 2x the upper reference value
Beskrivning

Creatinine i. S.: ≤ 2x the upper reference value

Datatyp

boolean

Written informed consent of the patient or the legal representative
Beskrivning

Written informed consent of the patient or the legal representative

Datatyp

boolean

Exclusion criteria
Beskrivning

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Participate in this study at an earlier date
Beskrivning

Participate in this study at an earlier date

Datatyp

boolean

Serious psychiatric pre-/concomitant disease
Beskrivning

Serious psychiatric pre-/concomitant disease

Datatyp

boolean

Pregnancy or lactation
Beskrivning

Pregnancy or lactation

Datatyp

boolean

Women of childbearing age with insufficient or unsecured contraception
Beskrivning

Women of childbearing age with insufficient or unsecured contraception

Datatyp

boolean

Proof of probable or proven invasive active Fungal infection at the time of study inclusion (see EORTC / MSG-defi nition)
Beskrivning

Proof of probable or proven invasive active Fungal infection at the time of study inclusion (see EORTC / MSG-defi nition)

Datatyp

boolean

Patient with pathological function parameters of liver and kidney function
Beskrivning

Patient with pathological function parameters of liver and kidney function

Datatyp

boolean

Total bilirubin:> 3x upper reference value
Beskrivning

Total bilirubin:> 3x upper reference value

Datatyp

boolean

SGOT or SGPT:> 3x upper reference value
Beskrivning

SGOT or SGPT:> 3x upper reference value

Datatyp

boolean

Alkaline phosphatase:> 5x the upper reference value
Beskrivning

Alkaline phosphatase:> 5x the upper reference value

Datatyp

boolean

Creatinine i. S.:> 2x upper reference value
Beskrivning

Creatinine i. S.:> 2x upper reference value

Datatyp

boolean

Clinical and/or laboratory evidence of active veno-occlusive disease. VOD is characterized by an increase in serum transaminases and following a persistent increase in serum bilirubin and liver tenderness, weight gain and ascites
Beskrivning

Clinical and/or laboratory evidence of active veno-occlusive disease. VOD is characterized by an increase in serum transaminases and following a persistent increase in serum bilirubin and liver tenderness, weight gain and ascites

Datatyp

boolean

Hemodynamically instablier patient or patient with an anticipated Survival time of <5 days
Beskrivning

Hemodynamically instablier patient or patient with an anticipated Survival time of <5 days

Datatyp

boolean

Concomitant use of rifampicin, phenytoin, carbamazepine, phenobarbital, Dexamethasone, efavirenz and nevirapine
Beskrivning

Concomitant use of rifampicin, phenytoin, carbamazepine, phenobarbital, Dexamethasone, efavirenz and nevirapine

Datatyp

boolean

Patient with a history of intolerance to echinocandin antifungals or documented allergic reactions to amphotericin B
Beskrivning

Patient with a history of intolerance to echinocandin antifungals or documented allergic reactions to amphotericin B

Datatyp

boolean

Any other condition or circumstance, that in the opinion of the attending physician pose a risk for the patient, impair the protocol-compliant therapy of the patient, and could affect the objective of the study
Beskrivning

Any other condition or circumstance, that in the opinion of the attending physician pose a risk for the patient, impair the protocol-compliant therapy of the patient, and could affect the objective of the study

Datatyp

boolean

Missing or incomplete consent
Beskrivning

Missing or incomplete consent

Datatyp

boolean

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Similar models

Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Adult Patient (≥ 18 years) with granulocytopenia (absolute number neutrophil: ≤500 / μl) and allogeneic hematopoietic condition after Stem cell transplantation and immunosuppression with cyclosporine A
Item
Adult Patient (>=18 years) with granulocytopenia (absolute number neutrophil: <=500 / ul) and allogeneic hematopoietic condition after Stem cell transplantation and immunosuppression with cyclosporine A
boolean
Patient with persistent or relapsed fever (oral temperature ≥38.0°C) and granulocytopenia (absolute Neutrophil Count ≤500 / μl) and adequate antibacterial therapy for ≥36-48 Hours in need of empirical antifungal therapy A
Item
Patient with persistent or relapsed fever (oral temperature ≥38.0°C) and granulocytopenia (absolute Neutrophil Count ≤500 / μl) and adequate antibacterial therapy for ≥36-48 Hours in need of empirical antifungal therapy A
boolean
Reclining, at least double-recurrent central venous catheters for administration of drugs and for the extraction of plasma samples
Item
Reclining, at least double-recurrent central venous catheters for administration of drugs and for the extraction of plasma samples
boolean
For patients of childbearing age: existence of a negative Pregnancy tests within 7 days prior to initiation of treatment and adequate contraception during study participation
Item
For patients of childbearing age: existence of a negative Pregnancy tests within 7 days prior to initiation of treatment and adequate contraception during study participation
boolean
Life expectancy ≥5 days
Item
Life expectancy ≥5 days
boolean
Treatment in one of said test centers
Item
Treatment in one of said test centers
boolean
Adequate renal and hepatic function in accordance with the following definitions
Item
Adequate renal and hepatic function in accordance with the following definitions
boolean
Bilirubin Total: ≤ 3x upper reference value
Item
Bilirubin Total: ≤ 3x upper reference value
boolean
SGOT or SGPT: ≤ 3x upper reference value
Item
SGOT or SGPT: ≤ 3x upper reference value
boolean
Alkaline phosphatase: ≤ 5x upper reference value
Item
Alkaline phosphatase: ≤ 5x upper reference value
boolean
Creatinine i. S.: ≤ 2x the upper reference value
Item
Creatinine i. S.: ≤ 2x the upper reference value
boolean
Written informed consent of the patient or the legal representative
Item
Written informed consent of the patient or the legal representative
boolean
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Participate in this study at an earlier date
Item
Participate in this study at an earlier date
boolean
Serious psychiatric pre-/concomitant disease
Item
Serious psychiatric pre-/concomitant disease
boolean
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
Women of childbearing age with insufficient or unsecured contraception
Item
Women of childbearing age with insufficient or unsecured contraception
boolean
Proof of probable or proven invasive active Fungal infection at the time of study inclusion (see EORTC / MSG-defi nition)
Item
Proof of probable or proven invasive active Fungal infection at the time of study inclusion (see EORTC / MSG-defi nition)
boolean
Patient with pathological function parameters of liver and kidney function
Item
Patient with pathological function parameters of liver and kidney function
boolean
Total bilirubin:> 3x upper reference value
Item
Total bilirubin:> 3x upper reference value
boolean
SGOT or SGPT:> 3x upper reference value
Item
SGOT or SGPT:> 3x upper reference value
boolean
Alkaline phosphatase:> 5x the upper reference value
Item
Alkaline phosphatase:> 5x the upper reference value
boolean
Creatinine i. S.:> 2x upper reference value
Item
Creatinine i. S.:> 2x upper reference value
boolean
Clinical and/or laboratory evidence of active veno-occlusive disease. VOD is characterized by an increase in serum transaminases and following a persistent increase in serum bilirubin and liver tenderness, weight gain and ascites
Item
Clinical and/or laboratory evidence of active veno-occlusive disease. VOD is characterized by an increase in serum transaminases and following a persistent increase in serum bilirubin and liver tenderness, weight gain and ascites
boolean
Hemodynamically instablier patient or patient with an anticipated Survival time of <5 days
Item
Hemodynamically instablier patient or patient with an anticipated Survival time of <5 days
boolean
Concomitant use of rifampicin, phenytoin, carbamazepine, phenobarbital, Dexamethasone, efavirenz and nevirapine
Item
Concomitant use of rifampicin, phenytoin, carbamazepine, phenobarbital, Dexamethasone, efavirenz and nevirapine
boolean
Patient with a history of intolerance to echinocandin antifungals or documented allergic reactions to amphotericin B
Item
Patient with a history of intolerance to echinocandin antifungals or documented allergic reactions to amphotericin B
boolean
Any other condition or circumstance, that in the opinion of the attending physician pose a risk for the patient, impair the protocol-compliant therapy of the patient, and could affect the objective of the study
Item
Any other condition or circumstance, that in the opinion of the attending physician pose a risk for the patient, impair the protocol-compliant therapy of the patient, and could affect the objective of the study
boolean
Missing or incomplete consent
Item
Missing or incomplete consent
boolean
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