Clinical trial NCT04174053: Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
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
Overall status: UNKNOWN
Phase: NA
Conditions: Haematological Malignancy
Keywords: Temperature measurement
capsule thermometers
Haematology
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule
timeFrame: 6 months
Secondary outcomes:
measure: Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration
timeFrame: 6 months
measure: Description of curves of temperature in the neutropenic patient measured continuously
timeFrame: 6 months
measure: Satisfaction of patient towards enteric capsule
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Fabrice Jardin, Professor
role: PRINCIPAL_INVESTIGATOR
References: