Home Away From Home - Medical Outcomes
- Conditions
- NeutropeniaBacteremiaAcute Myeloid Leukemia
- Registration Number
- NCT02774850
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 610
- Males or females of age less than 19 at diagnosis.
- Receipt or planned receipt of AML chemotherapy between January 1, 2012 and December 31, 2019.
- Patients being treated for relapsed AML
- Patients with Acute Promyelocytic Leukemia (APML)
- Patients undergoing stem cell transplant (SCT)
- Patients receiving reduced intensity frontline chemotherapy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (17)
Children's Hospital of Philadelphia
๐บ๐ธPhiladelphia, Pennsylvania, United States
Lucile Packard Children's Hospital
๐บ๐ธPalo Alto, California, United States
Children's Hospital of Colorado
๐บ๐ธAurora, Colorado, United States
Rady Children's Hospital
๐บ๐ธSan Diego, California, United States
Alfred I DuPont Hospital for Children
๐บ๐ธWilmington, Delaware, United States
Ann & Robert H Lurie Children's Hospital
๐บ๐ธChicago, Illinois, United States
Ochsner Medical Center
๐บ๐ธNew Orleans, Louisiana, United States
C.S. Mott Children's Hospital
๐บ๐ธAnn Arbor, Michigan, United States
Dana-Farber Cancer Institute/Boston Children's Hospital
๐บ๐ธBoston, Massachusetts, United States
Children's Hospital of Michigan
๐บ๐ธDetroit, Michigan, United States
University of Mississippi Medical Center
๐บ๐ธJackson, Mississippi, United States
Children's Medical Center of Dallas
๐บ๐ธDallas, Texas, United States
Texas Children's Hospital
๐บ๐ธHouston, Texas, United States
Primary Children's Hospital
๐บ๐ธSalt Lake City, Utah, United States
Seattle Children's Hospital
๐บ๐ธSeattle, Washington, United States
Children's Healthcare of Atlanta
๐บ๐ธAtlanta, Georgia, United States
Arkansas Children's Hospital
๐บ๐ธLittle Rock, Arkansas, United States