Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute leukemia patients | Patients with de novo or relapsed acute myeloid and lymphoid leukemia | ||
| Allo- or auto- transplant recipients |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Invasive Fungal Infections | Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation. | 6 month |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Galina A Klyasova | National Research Center for Hematology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hematological Society | Moscow | 119021 | Russia |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Acute Leukemia Patients | Patients with de novo or relapsed acute myeloid and lymphoid leukemia |
| FG001 | Allo- or Auto- Transplant Recipients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acute Leukemia Patients | Patients with de novo or relapsed acute myeloid and lymphoid leukemia |
| BG001 | Allo- or Auto- Transplant Recipients | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Rate of Invasive Fungal Infections | Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation. | Posted | Number | participants | 6 month |
|
|
|
|
Not provided
The study was observational and the adverse events were not evaluated
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Leukemia Patients | Patients with de novo or relapsed acute myeloid and lymphoid leukemia | 0 | 0 | 0 | 0 | ||
| EG001 | Allo- or Auto- Transplant Recipients | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Galina A Klyasova | National Hematological Society | +7(495)6125181 | klyasova.g@blood.ru |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D009503 | Neutropenia |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|