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Completed
Conditions
Neutropenia
Bacteremia
Acute 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
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Occurrence of Post-chemotherapy BacteremiaIdentification 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
NameTimeMethod
Time to the Initiation of the Next Chemotherapy CourseThe 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

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Philadelphia, Pennsylvania, United States

Lucile Packard Children's Hospital

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Palo Alto, California, United States

Children's Hospital of Colorado

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Aurora, Colorado, United States

Rady Children's Hospital

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San Diego, California, United States

Alfred I DuPont Hospital for Children

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Wilmington, Delaware, United States

Ann & Robert H Lurie Children's Hospital

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Chicago, Illinois, United States

Ochsner Medical Center

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New Orleans, Louisiana, United States

C.S. Mott Children's Hospital

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Ann Arbor, Michigan, United States

Dana-Farber Cancer Institute/Boston Children's Hospital

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Boston, Massachusetts, United States

Children's Hospital of Michigan

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Detroit, Michigan, United States

University of Mississippi Medical Center

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Jackson, Mississippi, United States

Children's Medical Center of Dallas

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Dallas, Texas, United States

Texas Children's Hospital

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Houston, Texas, United States

Primary Children's Hospital

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Salt Lake City, Utah, United States

Seattle Children's Hospital

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Seattle, Washington, United States

Children's Healthcare of Atlanta

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Atlanta, Georgia, United States

Arkansas Children's Hospital

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Little Rock, Arkansas, United States

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