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

Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

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.

Study Overview

• Status: Unknown
• Conditions: Haematological Malignancy
• Intervention / Treatment: Device: Enteric capsule

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
    • Contact: Fabrice Jardin; Phone Number: +33232082909; Email: fabrice.jardin@chb.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6 months
Description of curves of temperature in the neutropenic patient measured continuously	Description of curves of temperature in the neutropenic patient measured continuously	6 months
Satisfaction of patient towards enteric capsule	auto-questionnaire	6 months

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Fabrice Jardin, Professor, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Haematology; Temperature measurement; capsule thermometers
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: CHB18.09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No