Invasive Fungal Infections
Conditions
Keywords
Invasive fungal infection, Acute leukemia (AL), Hematopoietic stem cell transplantation, Antifungal stewardship, Neutropenia, Hematological malignancies
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
National Hematological Society, Russia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy * All newly allogeneic or autologous transplant recipients during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Invasive Fungal Infections | 6 month | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acute Leukemia Patients Patients with de novo or relapsed acute myeloid and lymphoid leukemia | 502 |
| Allo- or Auto- Transplant Recipients | 306 |
| Total | 808 |
Baseline characteristics
| Characteristic | Acute Leukemia Patients | Allo- or Auto- Transplant Recipients | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 69 Participants | 55 Participants | 124 Participants |
| Age, Categorical >=65 years | 44 Participants | 1 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 389 Participants | 250 Participants | 639 Participants |
| Age, Continuous | 42 years | 37 years | 40 years |
| Region of Enrollment Russian Federation | 502 participants | 306 participants | 808 participants |
| Sex: Female, Male Female | 261 Participants | 150 Participants | 411 Participants |
| Sex: Female, Male Male | 241 Participants | 156 Participants | 397 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 6 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Acute Leukemia Patients | The Rate of Invasive Fungal Infections | 77 participants |
| Allo- or Auto- Transplant Recipients | The Rate of Invasive Fungal Infections | 27 participants |
p-value: 0.00795% CI: [1.178, 2.977]Chi-squared