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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04081753

Acronym

REMEDY

Enrollment

Registered

2019-09-09

Start date

2019-12-16

Completion date

2024-07-31

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia (AML)

Keywords

HiDAC, Neutropenia, Fever, AML, Leukemia

Brief summary

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.

Interventions

DEVICERemote monitoring of temperature

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Interventional group will be compared with historic group of patients

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change ICU admission	1 month	The interventional group will have changed in the number of ICU admission.
Change incidence of sepsis in interventional group	1 month	The interventional group will have changed rate of sepsis incidence.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026