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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Myeloid Leukemia (AML)

Intervention / Treatment
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* Device: Remote monitoring of temperature


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional group will be compared with historic group of patients
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMD Group<br>Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely. | Device: Remote monitoring of temperature<br>* The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely<br>|
| No Intervention: Historic cohort Group<br>Historic cohort group will be enrolled from medical record | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change ICU admission | The interventional group will have less number of ICU admission | 1 month | 
| Change incidence of sepsis in interventional group | The interventional group will have chnaged rate of sepsis incidence | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HiDAC, Neutropenia, Fever, AML, Leukemia