Flow Cytometry Analysis of the Reactive Oxygen Species in Immature Granulocytes in Septic Patient (SEPSIROS)

April 7, 2020 updated by: University Hospital, Limoges
Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Early during sepsis course, immature neutrophils could be found in the bloodstream and may be less efficient than mature neutrophils in reactive oxygen species (ROS) production. ROS induce an oxidative stress for bacteria which can protect through the SOS response. The main objective is to evaluate the level of ROS produced in the early steps of sepsis by the immature neutrophils.

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.

Detailed Description

Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. The immune system is activated by both pathogen-associated and host-derived molecular patterns. A strong response of neutrophils is engaged and both innate and adaptive immune system homeostasis are strongly affected. Neutrophils are able to produce high concentrations of inducible reactive oxygen species (ROS), leading to an oxidative stress. ROS can be released extracellularly at the site of infection or intracellularly in the phagolysosome. At early phase of sepsis, immature granulocytes are present in the bloodstream and could help to predict sepsis deterioration. However, it has also been shown that they are less efficient than mature granulocytes in ROS production and phagocytosis. ROS are potent stressors for bacteria and can directly or indirectly damage DNA. Bacteria can protect against DNA damage through the SOS response, which is a coordinated cellular response regulated by a repressor, LexA, and a sensor/activator, RecA. The bacterial SOS response is involved in acquisition of resistances to antibiotics through increasing frequencies of spontaneous mutations or increasing the expression of resistance and adaptation genes. The hypothesis that the low-level production of ROS by immature granulocytes in the early steps of sepsis could be beneficial for both the host, as a high level of ROS induce organ damage and dysfunction, and the pathogen, as low concentrations of ROS would be able to induce the SOS response allowing bacteria to enhance an adaptive response. The main objective it is to evaluate the level of ROS produced by the immature granulocytes in septic patient. Then, it will be assess if it could promote antibiotic resistance expression via SOS-induced integron gene cassette rearrangements.

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.
Observational

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.
34

Contacts and Locations

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

Study Locations

  • France
      • Limoges, France, 87042
        • Limoges University hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient hospitalized in intensive car or emergency department for acute sepsis

Description

Inclusion Criteria:

• Adult patients hospitalized in ICU or ED for acute sepsis

Exclusion Criteria:

  • Immunosupressed patients
  • Active cancer
  • HIV
  • Hematological or inflammatory diseases

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Evaluated
An additional blood tube will be taken from patients hospitalized in intensive care or emergency department for acute sepsis
Biological: Additional blood tube
Additional blood tube during care

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
ROS level by Flow cytometry in immature granulocytes dosage sepsis
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the immature granulocytes from the onset of sepsis to the acute phase
Day 1

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
ROS level by Flow cytometry in mature granulocytes dosage sepsis
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the mature granulocytes from the onset of sepsis to the acute phase
Day 1
Bacterial phagocytosis capacity of granulocytes assess by flow cytometry
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the number of ingested bacteria.
Day 1
SOS response activation by bacteria determined by flow cytometry
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the expression of the SOS gene by the bacteria.
Day 1
Hospital mortality
Time Frame: Day 28
number of death
Day 28
ROS level by Flow cytometry in monocyte dosage sepsis
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the monocyte from the onset of sepsis to the acute phase
Day 1
ROS level by Flow cytometry in lymphocyte dosage sepsis
Time Frame: Day 1
The biological variable obtained is an average of fluorescence intensity (MFI) corresponding to the amount of ROS contained in the lymphocyte from the onset of sepsis to the acute phase
Day 1

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, Limoges

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas DAIX, MD, University Hospital, Limoges

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.
March 26, 2019

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.
March 10, 2020

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.
March 10, 2020

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).
February 15, 2019

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.
February 18, 2019

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.
February 19, 2019

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.
April 8, 2020

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.
April 7, 2020

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.
April 1, 2020

More Information

Terms related to this study

Keywords

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.
  • 87RI18-0031 (SEPSIROS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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