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Completed

NCT Number: NCT04174053

Concordance Between 2 Means of Temperature Measure 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.

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Key information

Conditions

Haematological Malignancy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Henri Becquerel

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Description of curves of temperature in the neutropenic patient measured continuously

    Time frame: 6 months

    Description of curves of temperature in the neutropenic patient measured continuously

  3. Satisfaction of patient towards enteric capsule

    Time frame: 6 months

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Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: TEMPET

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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