Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intens… (NCT04174053) | Clinical Trial Compass
CompletedNot Applicable
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units
France30 participantsStarted 2019-06-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the concordance between the body temperature measured at the periphery by ear thermometer and the body temperature measured per enteric capsule