Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy

Febrile neutropenic patients are at high risk for developing sepsis and other infections which often necessitates acute admission to the Intensive Care Unit (ICU) and are associated with high mortality. Neutropenic fever is a medical emergency and early detection of fever allows for prompt infectious work up. In this study, the investigators will collect pilot data from outpatients utilizing a remote outpatient continuous temperature monitoring device to compare the incidence of ICU admission and severe sepsis to historical data for prior patients who did not receive at home monitoring device.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Agranulocytosis Body Temperature Changes Cytopenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neutropenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who have acute myeloid leukemia (AML) and are candidates for consolidation chemotherapy with high dose cytarabine (HiDAC) after successful remission induction chemotherapy

Both male and female
Age 18 years and older

Exclusion criteria

Patients who have already developed febrile neutropenia during their hospitalization for their consolidative cycle of chemotherapy will not be eligible for monitoring for that cycle; however, these patients will be able to participate in subsequent cycle if they do not develop febrile neutropenia during their subsequent HiDAC hospitalization.

If a patient is admitted to the hospital between cycles of chemotherapy for reasons other than febrile neutropenia or its sequelae, they will be taken off study for that cycle and data not collected while they are admitted

Treatment and study plan

Remote monitoring of temperature

Device

The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely

Primary outcomes

Change ICU admission

Time frame: 1 month

The interventional group will have changed in the number of ICU admission.
Change incidence of sepsis in interventional group

Time frame: 1 month

The interventional group will have changed rate of sepsis incidence.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

University of Georgia

Registry information

Acronym: REMEDY

Important dates

Study start: 2019
Primary completion: 2023
Study completion: 2024
First posted: Sep 9, 2019
Registry last updated: Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed