Haematological MalignancyTEMPETNCT04174053
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
A study testing Enteric capsule in people with Haematological Malignancy, run by Centre Henri Becquerel at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- Enteric capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jun 2019to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Haematological Malignancy
- Being tested
- Enteric capsule
- Keywords
- Temperature measurement, capsule thermometers, Haematology
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric capsuleDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Enteric capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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)
Measured: 6 months
Description of curves of temperature in the neutropenic patient measured continuously
Description of curves of temperature in the neutropenic patient measured continuously
Measured: 6 months
Satisfaction of patient towards enteric capsule
auto-questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start21 Jun 2019
- Primary completion7 Jul 2021
- Study completion7 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice Jardin, Professor, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174053
- Sponsor's protocol ID
- CHB18.09
- Acronym
- TEMPET
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2019
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
- ClinicalTrials.gov ID
- NCT04174053
- Acronym / sponsor ID
- TEMPET / CHB18.09
- Conditions
- Haematological Malignancy
- Keywords
- Temperature measurement, capsule thermometers, Haematology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 7 Jul 2021 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature measurement | Experimental | Device: Enteric capsuleenteric 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteric capsuleEnteric 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). | Device | Temperature measurement |
Primary outcome
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
3 secondary outcomes
Estimate of the theoretical administration date of the anti-infective if enteral temperature had been taken into consideration
Time frame: 6 months
Description of curves of temperature in the neutropenic patient measured continuously
Time frame: 6 months
Satisfaction of patient towards enteric capsule
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice Jardin, Professor principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteric capsule in people with Haematological Malignancy, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.