Back to resultsConcordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units (TEMPET)
Primary Purpose
Haematological Malignancy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Enteric capsule
Sponsored by
About this trial
This is an interventional other trial for Haematological Malignancy focused on measuring Temperature measurement, capsule thermometers, Haematology
Eligibility Criteria
Inclusion Criteria:
- Major patient admitted to USIH for an aplasia episode of at least 7 days secondary to:
- autograft conditioned by melphalan (MLP) or BEAM (BICNU, Etoposide, Aracytine, Melphalan) chemotherapy
- Aracytin chemotherapy High dose (HD) or intermediate dose (DI)
- Signed informed consent;
- Affiliated or beneficiary of a social protection scheme.
Exclusion Criteria:
- Diarrhea (> 3 stools /day) at the time of inclusion
- Occlusive syndrome at the time of inclusion or patient at risk of developing occlusive syndrome
- Persons with or likely to have intestinal disorders that may lead to obstruction of the digestive tract, including diverticulitis
- People with digestive tract motility disorders
- Persons equipped with a pacemaker or an electro-medical implant
- Weight < 40 kg or BMI > 30
- Patient for whom an MRI examination may be indicated during the trial period
- Patient with proven swallowing disorders
- Refusal to participate in the study
- Induction of acute leukaemia or allograft
- Person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
- Pregnant, parturient or breastfeeding women;
- Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problem, etc.)
- Patient who has already been included in the TEMPET trial during treatment
Sites / Locations
- Centre Henri BecquerelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Temperature measurement
Arm Description
enteric capsule will be ingested every 24 hours during aplasia. Temperature measurement will be made continuously during aplasia. In parallel, auricular temperature will be measure every 4 hours during aplasia.
Outcomes
Primary Outcome Measures
Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule
the temperature in degrees Celsius measured by the 2 systems (left and right average for the auricular measure) and analysis of the concordance
Secondary Outcome Measures
Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration
The time required to start anti-infective treatments according to the 2 measurement methods, in hours (effective start up thanks to the ear and theoretical measurement indicated by the enteric measurement)
Description of curves of temperature in the neutropenic patient measured continuously
Description of curves of temperature in the neutropenic patient measured continuously
Satisfaction of patient towards enteric capsule
auto-questionnaire
Full Information
NCT ID
NCT04174053
First Posted
November 20, 2019
Last Updated
November 20, 2019
Sponsor
Centre Henri Becquerel
1. Study Identification
Unique Protocol Identification Number
NCT04174053
Brief Title
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
Acronym
TEMPET
Official Title
Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.
However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancy
Keywords
Temperature measurement, capsule thermometers, Haematology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Temperature measurement
Arm Type
Experimental
Arm Description
enteric capsule will be ingested every 24 hours during aplasia. Temperature measurement will be made continuously during aplasia.
In parallel, auricular temperature will be measure every 4 hours during aplasia.
Intervention Type
Device
Intervention Name(s)
Enteric capsule
Intervention Description
Enteric capsule to measure body temperature will be ingested every 24 hours during aplasia. the temperature measured with this technique will be compared with auricular temperature measurement (in current practice nurse measure temperature every 4 hours during aplasia).
Primary Outcome Measure Information:
Title
Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule
Description
the temperature in degrees Celsius measured by the 2 systems (left and right average for the auricular measure) and analysis of the concordance
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration
Description
The time required to start anti-infective treatments according to the 2 measurement methods, in hours (effective start up thanks to the ear and theoretical measurement indicated by the enteric measurement)
Time Frame
6 months
Title
Description of curves of temperature in the neutropenic patient measured continuously
Description
Description of curves of temperature in the neutropenic patient measured continuously
Time Frame
6 months
Title
Satisfaction of patient towards enteric capsule
Description
auto-questionnaire
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major patient admitted to USIH for an aplasia episode of at least 7 days secondary to:
autograft conditioned by melphalan (MLP) or BEAM (BICNU, Etoposide, Aracytine, Melphalan) chemotherapy
Aracytin chemotherapy High dose (HD) or intermediate dose (DI)
Signed informed consent;
Affiliated or beneficiary of a social protection scheme.
Exclusion Criteria:
Diarrhea (> 3 stools /day) at the time of inclusion
Occlusive syndrome at the time of inclusion or patient at risk of developing occlusive syndrome
Persons with or likely to have intestinal disorders that may lead to obstruction of the digestive tract, including diverticulitis
People with digestive tract motility disorders
Persons equipped with a pacemaker or an electro-medical implant
Weight < 40 kg or BMI > 30
Patient for whom an MRI examination may be indicated during the trial period
Patient with proven swallowing disorders
Refusal to participate in the study
Induction of acute leukaemia or allograft
Person under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
Pregnant, parturient or breastfeeding women;
Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problem, etc.)
Patient who has already been included in the TEMPET trial during treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Jardin, Professor
Phone
+33232082909
Email
fabrice.jardin@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Doriane Richard, PhD
Phone
+33232082985
Email
doriane.richard@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Jardin, Professor
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Jardin
Phone
+33232082909
Email
fabrice.jardin@chb.unicancer.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
We'll reach out to this number within 24 hrs