NCT02774850

Home Away From Home - Medical Outcomes

Home or Away From Home: Comparing Clinical Outcomes Relevant to the Care of Pediatric Acute Myeloid Leukemia During Periods of Neutropenia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 610 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia
• Neutropenia
• Bacteremia

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-07-26
• Completion: 2019-07-26
• First posted: 2016-05-17
• Last updated: 2019-12-23
• Results posted: 2019-12-23

Locations

17 sites across 1 country: United States