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

NCT04174053 | Completed

• 1 other identifier: CHB18.09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Temperature measurement; capsule thermometers; Haematology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration

  6 months

• Description of curves of temperature in the neutropenic patient measured continuously

  6 months

• Satisfaction of patient towards enteric capsule

  6 months

Study Arms (1)

Temperature measurement

EXPERIMENTAL

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

Interventions

Enteric capsule 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).

Temperature measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76000, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Fabrice Jardin, Professor

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: June 21, 2019
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)