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

Haematological Malignancy Clinical Trial

— TEMPET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04174053
• Other study ID #: CHB18.09
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: July 2020

Study information

• Verified date: November 2019
• Source: Centre Henri Becquerel
• Contact: Fabrice Jardin, Professor
• Phone: +33232082909
• Email: fabrice.jardin[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haematological Malignancy
• Hematologic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Description of curves of temperature in the neutropenic patient measured continuously	Description of curves of temperature in the neutropenic patient measured continuously	6 months
Secondary	Satisfaction of patient towards enteric capsule	auto-questionnaire	6 months