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ID

12175

Description

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

Keywords

Versions (2)
  1. 10/6/15 10/6/15 -
  2. 10/6/15 10/6/15 - Martin Dugas
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October 6, 2015

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

    German English

    Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

    1 forms  
    Inclusion criteria
    Description

    Inclusion criteria

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

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

    Data type

    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
    Description

    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

    Data type

    boolean

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

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

    Data type

    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
    Description

    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

    Data type

    boolean

    Life expectancy ≥5 days
    Description

    Life expectancy ≥5 days

    Data type

    boolean

    Treatment in one of said test centers
    Description

    Treatment in one of said test centers

    Data type

    boolean

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

    Adequate renal and hepatic function in accordance with the following definitions

    Data type

    boolean

    Bilirubin Total: ≤ 3x upper reference value
    Description

    Bilirubin Total: ≤ 3x upper reference value

    Data type

    boolean

    SGOT or SGPT: ≤ 3x upper reference value
    Description

    SGOT or SGPT: ≤ 3x upper reference value

    Data type

    boolean

    Alkaline phosphatase: ≤ 5x upper reference value
    Description

    Alkaline phosphatase: ≤ 5x upper reference value

    Data type

    boolean

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

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

    Data type

    boolean

    Written informed consent of the patient or the legal representative
    Description

    Written informed consent of the patient or the legal representative

    Data type

    boolean

    Exclusion criteria
    Description

    Exclusion criteria

    Alias
    UMLS CUI-1
    C0680251 (Exclusion Criteria)
    Participate in this study at an earlier date
    Description

    Participate in this study at an earlier date

    Data type

    boolean

    Serious psychiatric pre-/concomitant disease
    Description

    Serious psychiatric pre-/concomitant disease

    Data type

    boolean

    Pregnancy or lactation
    Description

    Pregnancy or lactation

    Data type

    boolean

    Women of childbearing age with insufficient or unsecured contraception
    Description

    Women of childbearing age with insufficient or unsecured contraception

    Data type

    boolean

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

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

    Data type

    boolean

    Patient with pathological function parameters of liver and kidney function
    Description

    Patient with pathological function parameters of liver and kidney function

    Data type

    boolean

    Total bilirubin:> 3x upper reference value
    Description

    Total bilirubin:> 3x upper reference value

    Data type

    boolean

    SGOT or SGPT:> 3x upper reference value
    Description

    SGOT or SGPT:> 3x upper reference value

    Data type

    boolean

    Alkaline phosphatase:> 5x the upper reference value
    Description

    Alkaline phosphatase:> 5x the upper reference value

    Data type

    boolean

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

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

    Data type

    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
    Description

    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

    Data type

    boolean

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

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

    Data type

    boolean

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

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

    Data type

    boolean

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

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

    Data type

    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
    Description

    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

    Data type

    boolean

    Missing or incomplete consent
    Description

    Missing or incomplete consent

    Data type

    boolean

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    Similar models

    Inclusion and exclusion criteria Stem-Cell Transplantation CASLAMB NCT00148148

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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