- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04081753
Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy (REMEDY)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammad Mian, MBBS, PhD
- Phone Number: 706-723-0110
- Email: MMIAN@augusta.edu
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Augusta University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TMD Group
Temperature Monitoring Device Group - The interventional group, who will be given the temperature monitoring device and will be monitored remotely.
|
The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely
|
No Intervention: Historic cohort Group
Historic cohort group will be enrolled from medical record
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change ICU admission
Time Frame: 1 month
|
The interventional group will have changed in the number of ICU admission.
|
1 month
|
Change incidence of sepsis in interventional group
Time Frame: 1 month
|
The interventional group will have changed rate of sepsis incidence.
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Locke J. Bryan, MD, Augusta University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1464778
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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