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

NCT04081753 | Completed FDA Device

• 1 other identifier: 1464778
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

HiDAC; Neutropenia; Fever; AML; Leukemia

Outcome Measures

Primary Outcomes (2)

• Change ICU admission

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

  1 month

• Change incidence of sepsis in interventional group

  The interventional group will have changed rate of sepsis incidence.

  1 month

Study Arms (2)

TMD Group

EXPERIMENTAL

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

Historic cohort Group

NO INTERVENTION

Historic cohort group will be enrolled from medical record

Interventions

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

TMD Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead
• University of Georgia: collaborator

Study Sites (1)

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Related Publications (5)

• Pathak R, Giri S, Aryal MR, Karmacharya P, Bhatt VR, Martin MG. Mortality, length of stay, and health care costs of febrile neutropenia-related hospitalizations among patients with breast cancer in the United States. Support Care Cancer. 2015 Mar;23(3):615-7. doi: 10.1007/s00520-014-2553-0. Epub 2015 Jan 4.

  PMID: 25556610 BACKGROUND

• Saini L, Rostein C, Atenafu EG, Brandwein JM. Ambulatory consolidation chemotherapy for acute myeloid leukemia with antibacterial prophylaxis is associated with frequent bacteremia and the emergence of fluoroquinolone resistant E. Coli. BMC Infect Dis. 2013 Jun 22;13:284. doi: 10.1186/1471-2334-13-284.

  PMID: 23800256 BACKGROUND

• van Vliet M, Donnelly JP, Potting CM, Blijlevens NM. Continuous non-invasive monitoring of the skin temperature of HSCT recipients. Support Care Cancer. 2010 Jan;18(1):37-42. doi: 10.1007/s00520-009-0627-1. Epub 2009 Apr 25.

  PMID: 19396473 BACKGROUND

• Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, Raad II, Rolston KV, Young JA, Wingard JR; Infectious Diseases Society of America. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the infectious diseases society of america. Clin Infect Dis. 2011 Feb 15;52(4):e56-93. doi: 10.1093/cid/cir073.

  PMID: 21258094 BACKGROUND

• Taplitz RA, Kennedy EB, Bow EJ, Crews J, Gleason C, Hawley DK, Langston AA, Nastoupil LJ, Rajotte M, Rolston K, Strasfeld L, Flowers CR. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America Clinical Practice Guideline Update. J Clin Oncol. 2018 May 10;36(14):1443-1453. doi: 10.1200/JCO.2017.77.6211. Epub 2018 Feb 20.

  PMID: 29461916 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neutropenia; Fever; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Locke J. Bryan, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional group will be compared with historic group of patients

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 9, 2019
• Study Start: December 16, 2019
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)