Informations générales (source: ClinicalTrials.gov)
Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
Interventional
N/A
Centre Henri Becquerel (Voir sur ClinicalTrials)
juin 2019
juillet 2020
10 septembre 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Henri Becquerel - 76000 - Rouen - France | Fabrice Jardin | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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