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

Not Applicable

• Conditions: Haematological Malignancy
• Interventions: Device: Enteric capsule

• Registration Number: NCT04174053
• Lead Sponsor: Centre Henri Becquerel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-21
• Status Verified: 2019-11
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Last Update Submitted: 2019-11-20
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22
• Primary Completion: 2020-06
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Temperature measurement	Enteric capsule	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.

Primary Outcome Measures

Name	Time	Method
Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule	6 months	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

Name	Time	Method
Satisfaction of patient towards enteric capsule	6 months	auto-questionnaire
Description of curves of temperature in the neutropenic patient measured continuously	6 months	Description of curves of temperature in the neutropenic patient measured continuously
Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration	6 months	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)

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France