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

Primary Purpose

Acute Myeloid Leukemia (AML)

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Remote monitoring of temperature

About this trial

This is an interventional diagnostic trial for Acute Myeloid Leukemia (AML) focused on measuring HiDAC, Neutropenia, Fever, AML, Leukemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Augusta University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TMD Group

Historic cohort Group

Arm Description

Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.

Historic cohort group will be enrolled from medical record

Outcomes

Primary Outcome Measures

Change ICU admission

The interventional group will have less number of ICU admission

Change incidence of sepsis in interventional group

The interventional group will have chnaged rate of sepsis incidence

Secondary Outcome Measures

Full Information

NCT ID

NCT04081753

First Posted

September 5, 2019

Last Updated

January 6, 2020

Sponsor

Augusta University

Collaborators

University of Georgia

1. Study Identification

Unique Protocol Identification Number

NCT04081753

Brief Title

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

Acronym

REMEDY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 16, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Augusta University

Collaborators

University of Georgia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia (AML)

Keywords

HiDAC, Neutropenia, Fever, AML, Leukemia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Interventional group will be compared with historic group of patients

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TMD Group

Arm Type

Experimental

Arm Description

Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.

Arm Title

Historic cohort Group

Arm Type

No Intervention

Arm Description

Historic cohort group will be enrolled from medical record

Intervention Type

Device

Intervention Name(s)

Remote monitoring of temperature

Intervention Description

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

Primary Outcome Measure Information:

Title

Change ICU admission

Description

The interventional group will have less number of ICU admission

Time Frame

1 month

Title

Change incidence of sepsis in interventional group

Description

The interventional group will have chnaged rate of sepsis incidence

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammad Mian, MBBS, PhD

Phone

706-723-0110

MMIAN@augusta.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Locke J. Bryan, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Augusta University Medical Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammad Mian, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This study result will be used for service improvement of patient of the Augusta University Medical Center

Citations:

PubMed Identifier

25556610

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.

Results Reference

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PubMed Identifier

23800256

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.

Results Reference

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PubMed Identifier

19396473

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.

Results Reference

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PubMed Identifier

21258094

Citation

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.

Results Reference

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PubMed Identifier

29461916

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.

Results Reference

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

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