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ID
4576
Descrizione
The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.
Keywords
versioni (2)
- 11/12/13 11/12/13 - Martin Dugas
- 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
Caricato su
11 dicembre 2013
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00148148 # Stem-Cell Transplantation
Similar models
Eligibility
- StudyEvent: Eligibility
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
Male
boolean
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Adults (> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes [ANC]: < or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
boolean
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C2242529 (UMLS CUI)
10067862 (MDR)
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C2242529 (UMLS CUI)
10067862 (MDR)
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
InclusionCriterion_2
Item
Patients with persistent or recurrent fever (oral temperature > or = 38.0°C) and granulocytopenia (absolute neutrophil count < or = 500/µL) and adequate antibacterial therapy for > or = 36-48 hours, who need empirical antimycotic therapy
boolean
C0015967 (UMLS CUI)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C0854606 (UMLS CUI)
10042933 (MDR)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C0854606 (UMLS CUI)
10042933 (MDR)
InclusionCriterion_3
Item
Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
boolean
C0007435 (UMLS CUI)
10053377 (MDR)
10053377 (MDR)
InclusionCriterion_4
Item
Sufficient renal and hepatic function
boolean
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
C1848676 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
C1848676 (UMLS CUI)
InclusionCriterion_5
Item
Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
boolean
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
InclusionCriterion_6
Item
Availability of written informed consent from the patient or respectively from the legal representative after prior information
boolean
C0021430 (UMLS CUI)
ExclusionCriterion_1
Item
Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
boolean
C1262313 (UMLS CUI)
10062642 (MDR)
10062642 (MDR)
ExclusionCriterion_2
Item
Patients with pathological functional renal or hepatic parameters
boolean
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
boolean
C0948441 (UMLS CUI)
10062173 (MDR)
10062173 (MDR)
ExclusionCriterion_4
Item
Hemodynamically unstable patients with a life expectancy of less than 5 days
boolean
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
C0023671 (UMLS CUI)
MTHU021387 (LNC)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
C0023671 (UMLS CUI)
MTHU021387 (LNC)
ExclusionCriterion_5
Item
Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
boolean
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
ExclusionCriterion_6
Item
Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
boolean
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0571255 (UMLS CUI)
294340008 (SNOMED CT 2010_0731)
C1268551 (UMLS CUI)
129473008 (SNOMED CT 2010_0731)
C0002679 (UMLS CUI)
MTHU006779 (LNC)
77703004 (SNOMED CT 2010_0731)
C0571263 (UMLS CUI)
294349009 (SNOMED CT 2010_0731)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0571255 (UMLS CUI)
294340008 (SNOMED CT 2010_0731)
C1268551 (UMLS CUI)
129473008 (SNOMED CT 2010_0731)
C0002679 (UMLS CUI)
MTHU006779 (LNC)
77703004 (SNOMED CT 2010_0731)
C0571263 (UMLS CUI)
294349009 (SNOMED CT 2010_0731)
ExclusionCriterion_7
Item
Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient
boolean
CL102947 (UMLS CUI)
ExclusionCriterion_8
Item
Prior inclusion in the study
boolean
C1516879 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Neutropenia
Item
Neutropenia
string
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
Absolute Neutrophil Count
Item
Absolute Neutrophil Count
string
C0948762 (UMLS CUI)
10052033 (MDR)
10052033 (MDR)
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
Item
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
string
C2674490 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation
Item
Allogeneic Hematopoietic Stem Cell Transplantation
string
C2242529 (UMLS CUI)
10067862 (MDR)
10067862 (MDR)
Immunosuppressive therapy for transplant
Item
Immunosuppressive therapy for transplant
string
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
7447008 (SNOMED CT 2010_0731)
Cyclosporine
Item
Cyclosporine
string
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
Fever
Item
Fever
string
C0015967 (UMLS CUI)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
Continuous fever
Item
Continuous fever
string
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
271751000 (SNOMED CT 2010_0731)
Intermittent Pyrexia
Item
Intermittent Pyrexia
string
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
Systemic antibacterial therapy
Item
Systemic antibacterial therapy
string
C0854606 (UMLS CUI)
10042933 (MDR)
10042933 (MDR)
Catheterization, Central Venous
Item
Catheterization, Central Venous
string
C0007435 (UMLS CUI)
10053377 (MDR)
10053377 (MDR)
Normal renal function
Item
Normal renal function
string
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
81141003 (SNOMED CT 2010_0731)
Normal liver function
Item
Normal liver function
string
C1848676 (UMLS CUI)
Negative Pregnancy Test
Item
Negative Pregnancy Test
string
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Invasive mycosis
Item
Invasive mycosis
string
C1262313 (UMLS CUI)
10062642 (MDR)
10062642 (MDR)
Abnormal renal function
Item
Abnormal renal function
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Venoocclusive disease
Item
Venoocclusive disease
string
C0948441 (UMLS CUI)
10062173 (MDR)
10062173 (MDR)
Hemodynamic instability
Item
Hemodynamic instability
string
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
Life Expectancy
Item
Life Expectancy
string
C0023671 (UMLS CUI)
MTHU021387 (LNC)
MTHU021387 (LNC)
Rifampin
Item
Rifampin
string
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
Phenytoin
Item
Phenytoin
string
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
Carbamazepine
Item
Carbamazepine
string
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
Phenobarbital
Item
Phenobarbital
string
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
Dexamethasone
Item
Dexamethasone
string
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
Efavirenz
Item
Efavirenz
string
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
Nevirapine
Item
Nevirapine
string
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
Investigator
Item
Investigator
string
CL102947 (UMLS CUI)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)