Evolution of the Lymphocyte Phenotype in Patients With Infection in Intensive Care Unit (REAPHEN)

June 15, 2026 updated by: University Hospital, Brest
Patients admitted for polytrauma, severe neurological injury, post-operative monitoring or sepsis/septic shock present with significant inflammation, leading to immunoparalysis, which is responsible for infection, particularly prolonged infection. A study of their lymphocyte phenotype over time could help explore the phenomenon of immunoparalysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Brest, France, 29609
        • CHU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Postoperative esophagectomy surveillance within the last 24 hours.
  • Patients with intra-abdominal infection
  • Neurological patients with intubation planned for more than 24 hours (subarachnoid hemorrhage with coma, severe head trauma, ischemic or hemorrhagic stroke with coma).
  • Polytrauma with intubation planned for more than 24 hours
  • Patient aged 18 and over
  • Patient with social security coverage

Non-inclusion criteria :

  • Hereditary immune deficiency HIV-AIDS
  • Malignant hemopathies
  • Immunosuppressive treatment other than corticosteroid therapy or chemotherapy
  • Patient under legal protection
  • Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Phenotyping arm
There is only one arm in the study. All patients (i.e. our 4 target populations) will undergo the same phenotyping procedure.
Procedure: Lymphocyte Phenotyping Procedure

For all patients, lymphocyte phenotyping will be performed on biological samples taken on D0, D7 and the day of discharge. In case of infection, phenotyping will also be performed on the day of infection diagnosis and on the day corresponding to half the duration of antibiotic therapy.

For phenotyping, only 1.5 mL will be used. In case of infection, an additional 1mL will be collected (0.5mL on the day of inclusion diagnosis and 0.5 mL on the day corresponding to half the duration of antibiotic therapy). Blood is collected during sampling, which takes place several times a day as part of the standard management of these patients.

It is important to note that phenotyping is not routinely performed as part of routine care. An additional tube is therefore taken specifically for this analysis, but this is done without the need for an additional puncture.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lymphocytes numbers variation
Time Frame: Day 0
- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Day 0
Lymphocytes numbers variation
Time Frame: Day 7
- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Day 7
Lymphocytes numbers variation
Time Frame: Immediately upon prescribed discharge date
- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Immediately upon prescribed discharge date
Lymphocytes numbers variation
Time Frame: Immediately after diagnosis of infection
- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at diagnosis of infection according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Immediately after diagnosis of infection
Lymphocytes numbers variation
Time Frame: At the midpoint of the prescribed antibiotic course
- Numbers of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
At the midpoint of the prescribed antibiotic course
Lymphocytes percentages variation
Time Frame: Day 0
- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D0 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Day 0
Lymphocytes percentages variation
Time Frame: Day 7
- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at D7 according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Day 7
Lymphocytes percentages variation
Time Frame: Immediately upon prescribed discharge date
- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at discharge according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Immediately upon prescribed discharge date
Lymphocytes percentages variation
Time Frame: Immediately after diagnosis of infection
- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at day of diagnosis according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
Immediately after diagnosis of infection
Lymphocytes percentages variation
Time Frame: At the midpoint of the prescribed antibiotic course
- Percentage rate of various lymphocytes (LT, LB, NK and their subclasses) at half duration of infection's treatment according to reason for admission (postoperative vs sepsis/septic shock vs polytrauma vs neurological injury)
At the midpoint of the prescribed antibiotic course

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lymphocytes percentages variation in case of infection
Time Frame: Day 0
Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at D0
Day 0
Lymphocytes percentages variation in case of infection
Time Frame: At the onset of symptoms of infection
Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection
At the onset of symptoms of infection
Lymphocytes percentages variation in case of infection
Time Frame: Immediately following resolution of infection
Percentage rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection
Immediately following resolution of infection
Lymphocytes numbers variation in case of infection
Time Frame: Day 0
Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at D0
Day 0
Lymphocytes numbers variation in case of infection
Time Frame: Immediately after diagnosis of infection
Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at onset of infection
Immediately after diagnosis of infection
Lymphocytes numbers variation in case of infection
Time Frame: Immediately following resolution of infection
Numbers rate in various lymphocytes (LT, LB, NK and their subclasses) at resolution of infection
Immediately following resolution of infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 3, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC23.0109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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