ID

12175

Beschrijving

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

Trefwoorden

Versies (2)
  1. 06-10-15 06-10-15 -
  2. 06-10-15 06-10-15 - Martin Dugas
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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

Duits Engels

Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

1 Formulieren  
Inclusion criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

boolean

Life expectancy ≥5 days
Beschrijving

Life expectancy ≥5 days

Datatype

boolean

Treatment in one of said test centers
Beschrijving

Treatment in one of said test centers

Datatype

boolean

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

Adequate renal and hepatic function in accordance with the following definitions

Datatype

boolean

Bilirubin Total: ≤ 3x upper reference value
Beschrijving

Bilirubin Total: ≤ 3x upper reference value

Datatype

boolean

SGOT or SGPT: ≤ 3x upper reference value
Beschrijving

SGOT or SGPT: ≤ 3x upper reference value

Datatype

boolean

Alkaline phosphatase: ≤ 5x upper reference value
Beschrijving

Alkaline phosphatase: ≤ 5x upper reference value

Datatype

boolean

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

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

Datatype

boolean

Written informed consent of the patient or the legal representative
Beschrijving

Written informed consent of the patient or the legal representative

Datatype

boolean

Exclusion criteria
Beschrijving

Exclusion criteria

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

Participate in this study at an earlier date

Datatype

boolean

Serious psychiatric pre-/concomitant disease
Beschrijving

Serious psychiatric pre-/concomitant disease

Datatype

boolean

Pregnancy or lactation
Beschrijving

Pregnancy or lactation

Datatype

boolean

Women of childbearing age with insufficient or unsecured contraception
Beschrijving

Women of childbearing age with insufficient or unsecured contraception

Datatype

boolean

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

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

Datatype

boolean

Patient with pathological function parameters of liver and kidney function
Beschrijving

Patient with pathological function parameters of liver and kidney function

Datatype

boolean

Total bilirubin:> 3x upper reference value
Beschrijving

Total bilirubin:> 3x upper reference value

Datatype

boolean

SGOT or SGPT:> 3x upper reference value
Beschrijving

SGOT or SGPT:> 3x upper reference value

Datatype

boolean

Alkaline phosphatase:> 5x the upper reference value
Beschrijving

Alkaline phosphatase:> 5x the upper reference value

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

boolean

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

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

Datatype

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
Beschrijving

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

Datatype

boolean

Missing or incomplete consent
Beschrijving

Missing or incomplete consent

Datatype

boolean

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Similar models

Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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