Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

NCT ID: NCT04174053

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-21
• Study Completion Date: 2021-07-07

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.

Conditions

Haematological Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Temperature measurement

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.

Group Type: EXPERIMENTAL

Enteric capsule

Intervention Type: DEVICE

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).

Interventions

Enteric capsule

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Henri Becquerel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Jardin, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

Centre Henri Becquerel

Rouen, , France

Countries

France

Other Identifiers

CHB18.09

Identifier Type: -

Identifier Source: org_study_id