Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026767
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2001-11-14
Brief Title:
Surveillance of Fungal Infections in Bone MarrowStem Cell and Organ Transplant Recipients
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Surveillance of Invasive Fungal Infections in Bone MarrowStem Cell and Solid Organ Transplantation Recipients and Other Immunocompromised Patients A Prospective Study
Status:
COMPLETED
Status Verified Date:
2012-07-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will collect data on the incidence rate of occurrence of fungal infections in recipients of bone marrow stem cell or organ transplants The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients
Any patient receiving bone marrow transplantation peripheral stem cell transplantation or solid organ transplantation is eligible for this study
The survey will be conducted over a 3-year period at about 20 collaborating transplant centers Through the annual accrual of more than 9000 patients it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections
The study will be conducted in three phases as follows
Phase 1 A 6-month start-up phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections
Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion
Phase 3 A 6-month wrap-up phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase
Patient care will be provided through the patient s primary protocol and standard of care
Any patient receiving bone marrow transplantation peripheral stem cell transplantation or solid organ transplantation is eligible for this study
The survey will be conducted over a 3-year period at about 20 collaborating transplant centers Through the annual accrual of more than 9000 patients it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections
The study will be conducted in three phases as follows
Phase 1 A 6-month start-up phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections
Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion
Phase 3 A 6-month wrap-up phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase
Patient care will be provided through the patient s primary protocol and standard of care
Detailed Description:
Background
Invasive fungal infections have emerged as important causes of morbidity and mortality among recipients of bone marrow stem cell and solid organ transplantation SOT as well as patients receiving intensive chemotherapy for treatment of hematological malignancies patients with aplastic anemia and patients with inherited immunodeficiencies
This study has been formerly conducted through a surveillance network of BMTSCT and SOT centers through collaboration with the Centers for Disease Control for the surveillance of invasive fungal infections in recipients of bone marrow stem cell transplantation and solid organ transplantations
The first three phases of this study will have been conducted over a six-year period at approximately 23 collaborating transplant centers and completed enrollment of multi-center cases of March 31 2006
The addition of a fourth phase allows the study of cases of invasive fungal infections to continue by extending the protocol for four years at the NIH Clinical Center
It is estimated that at least 5-8 of immunocompromised patients will be accrued annually with documented or suspected invasive fungal infections
Objectives
The objective of this study is to conduct multi-institutional surveillance for invasive fungal infections in recipients of bone marrow stem cell transplantation and solid organ transplantations as well as in immunocompromised patients within the Clinical Center patient population
To maintain a multi-institute surveillance network to evaluate new approaches to the prevention and diagnosis of invasive fungal infections through the analysis of immune function to include antigen detection within the population of patients who develop invasive fungal infections
Eligibility
Any patient within the NIH Clinical Center receiving a bone marrow transplantation peripheral stem cell transplantation or solid organ transplantation or any patient with an inherited immunodeficiency aplastic anemia or oncologic diagnosis meeting EORTCMSG criteria for an invasive infection
Design
This is a prospective surveillance study of invasive fungal infections in the immunocompromised host population
An incident case will be defined as any transplant recipient or an immunocompromised patient ie having inherited immunodeficiencies aplastic anemia or general oncology with proven or probable invasive fungal infection meeting the criteria for IFI as described by the MSGEORTC guidelines
Positive microbiological evidence will prompt acquisition of discarded serum and blood from the Department of Laboratory Medicine for analysis of immune function to include antigen detection to evaluate new approaches to the prevention and diagnosis of invasive fungal infections
Invasive fungal infections have emerged as important causes of morbidity and mortality among recipients of bone marrow stem cell and solid organ transplantation SOT as well as patients receiving intensive chemotherapy for treatment of hematological malignancies patients with aplastic anemia and patients with inherited immunodeficiencies
This study has been formerly conducted through a surveillance network of BMTSCT and SOT centers through collaboration with the Centers for Disease Control for the surveillance of invasive fungal infections in recipients of bone marrow stem cell transplantation and solid organ transplantations
The first three phases of this study will have been conducted over a six-year period at approximately 23 collaborating transplant centers and completed enrollment of multi-center cases of March 31 2006
The addition of a fourth phase allows the study of cases of invasive fungal infections to continue by extending the protocol for four years at the NIH Clinical Center
It is estimated that at least 5-8 of immunocompromised patients will be accrued annually with documented or suspected invasive fungal infections
Objectives
The objective of this study is to conduct multi-institutional surveillance for invasive fungal infections in recipients of bone marrow stem cell transplantation and solid organ transplantations as well as in immunocompromised patients within the Clinical Center patient population
To maintain a multi-institute surveillance network to evaluate new approaches to the prevention and diagnosis of invasive fungal infections through the analysis of immune function to include antigen detection within the population of patients who develop invasive fungal infections
Eligibility
Any patient within the NIH Clinical Center receiving a bone marrow transplantation peripheral stem cell transplantation or solid organ transplantation or any patient with an inherited immunodeficiency aplastic anemia or oncologic diagnosis meeting EORTCMSG criteria for an invasive infection
Design
This is a prospective surveillance study of invasive fungal infections in the immunocompromised host population
An incident case will be defined as any transplant recipient or an immunocompromised patient ie having inherited immunodeficiencies aplastic anemia or general oncology with proven or probable invasive fungal infection meeting the criteria for IFI as described by the MSGEORTC guidelines
Positive microbiological evidence will prompt acquisition of discarded serum and blood from the Department of Laboratory Medicine for analysis of immune function to include antigen detection to evaluate new approaches to the prevention and diagnosis of invasive fungal infections
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-C-0144 | None | None | None |