Acute Myeloid Leukemia, Bacteremia, Neutropenia
Conditions
Keywords
Pediatric, Neutropenia Management, Acute Myeloid Leukemia, Chart Abstraction, Chemotherapy
Brief summary
Treatment for pediatric acute myeloid leukemia (AML) involves intensive chemotherapy regimens that result in periods of profound neutropenia leaving patients susceptible to severe infectious complications. Infectious complications are the leading cause of treatment related mortality among AML patients, but there are little clinical data to inform whether management of neutropenia post AML chemotherapy should occur in an outpatient or inpatient setting. The primary objective of this study is to compare the clinical effectiveness of outpatient versus inpatient management of neutropenia in children with AML.
Detailed description
This is a bidirectional observational cohort study. Participants will be patients less that 19 years of age at diagnosis receiving or having received chemotherapy for AML from seventeen participating pediatric hospitals across the United States. There is no study intervention; this is a medical record abstraction study only. Investigators will abstract subjects medical record data over the study period in order to study clinical outcomes including the occurrence of bacteremia and time to the start of the next course in the chemotherapy regimen, in relation to neutropenia management strategy.
Interventions
None listed
Sponsors
C.S. Mott Children's Hospital
Children's Healthcare of Atlanta
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Medical Center Dallas
Children's Hospital of Michigan
Baylor College of Medicine
University of Mississippi Medical Center
Arkansas Children's Hospital Research Institute
Ochsner Health System
Lucile Packard Children's Hospital
Primary Children's Hospital
Rady Children's Hospital, San Diego
Seattle Children's Hospital
Patient-Centered Outcomes Research Institute
Children's Hospital Colorado
Alfred I. duPont Hospital for Children
Dana-Farber Cancer Institute
Children's Hospital of Philadelphia
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
No minimum to 19 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females of age less than 19 at diagnosis. 2. Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.
Exclusion criteria
1. Patients being treated for relapsed AML 2. Patients with Acute Promyelocytic Leukemia (APML) 3. Patients undergoing stem cell transplant (SCT) 4. Patients receiving reduced intensity frontline chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Post-chemotherapy Bacteremia | Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course. | Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the Initiation of the Next Chemotherapy Course | The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course | Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course. |
Countries
United States
Participant flow
Pre-assignment details
610 patients reflects the total number of patients included in chart abstractions; from there exclusion criteria were applied to determine early discharge eligibility. They were assigned to Early Discharge Management and Inpatient Management by chemotherapy course, not by the overall treatment.
Participants by arm
| Arm | Count |
|---|---|
| Early Discharge Management Discharge to outpatient management during neutropenia within 3 days after chemotherapy completion in a given course | 114 |
| Inpatient Management Remain hospitalized during chemotherapy-induced neutropenia | 379 |
| Total | 493 |
Baseline characteristics
| Characteristic | Inpatient Management | Total | Early Discharge Management |
|---|---|---|---|
| Age, Categorical <=18 years | 379 Participants | 493 Participants | 114 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity Hispanic Ethnicity | 77 Participants | 106 Participants | 29 Participants |
| Race/Ethnicity, Customized Hispanic Ethnicity Not Hispanic Ethnicity | 302 Participants | 387 Participants | 85 Participants |
| Race/Ethnicity, Customized Race Asian | 26 Participants | 37 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Black | 74 Participants | 91 Participants | 17 Participants |
| Race/Ethnicity, Customized Race Not recorded in EMR | 11 Participants | 12 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 44 Participants | 77 Participants | 33 Participants |
| Race/Ethnicity, Customized Race White | 224 Participants | 276 Participants | 52 Participants |
| Region of Enrollment United States | 379 participants | 493 participants | 114 participants |
| Sex: Female, Male Female | 192 Participants | 245 Participants | 53 Participants |
| Sex: Female, Male Male | 187 Participants | 248 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Occurrence of Post-chemotherapy Bacteremia
Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC \> 200 uL), or until the start of the next course (for a very small number of patients who begin the next course of chemotherapy prior to count recovery). Bacteremia will be defined as a single positive blood culture for a bacterial pathogen (including Viridans group Streptococci). If the bacterium is an organism considered as a common commensal organism by the National Healthcare Safety Network, two separate positive blood cultures will be required for classification as bacteremia.
Time frame: Identification of bacteremia will begin three days after completion of a chemotherapy course and will continue until recovery of absolute neutrophil count (ANC > 200 uL), or until the start of the next course.
Population: Patients in study course Induction II analyzed for bacteremia for this course.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early Discharge Management | Occurrence of Post-chemotherapy Bacteremia | 22 Participants |
| Inpatient Management | Occurrence of Post-chemotherapy Bacteremia | 81 Participants |
Secondary
Time to the Initiation of the Next Chemotherapy Course
Time to next course of chemotherapy will be measured as the number of days from the three days after the completion chemotherapy in a given course until the first day of the next course.
Time frame: The number of days from the three days after the completion chemotherapy in a given course until the first day of the next course
Population: Patients in Induction II who were analyzed for the amount of time (in days) it took for them to start their next chemotherapy course.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early Discharge Management | Time to the Initiation of the Next Chemotherapy Course | 31.5 days | Standard Deviation 9.4 |
| Inpatient Management | Time to the Initiation of the Next Chemotherapy Course | 27.8 days | Standard Deviation 7.6 |