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.
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.
Study Type
OBSERVATIONAL
Enrollment
610
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Alfred I DuPont Hospital for Children
Wilmington, Delaware, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital
Chicago, Illinois, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Dana-Farber Cancer Institute/Boston Children's Hospital
Boston, Massachusetts, United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
...and 7 more locations
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.
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
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