NCT04081753Completed
Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After Chemotherapy
Source: ClinicalTrials.gov · Last updated 23 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 5 Sept 2019
- Start date
- 16 Dec 2019
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- Augusta University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04081753
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 16 Dec 2019 to the primary completion date, 30 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.