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

Acute Myeloid Leukemia (AML) Clinical Trial

— REMEDY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081753
• Other study ID #: 1464778
• Status: Completed
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Febrile Neutropenia
• Leukemia, Myeloid, Acute
• Neutropenia

Intervention

Device:
• Remote monitoring of temperature
The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely

Locations

Country	Name	City	State
United States	Augusta University Medical Center	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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