Characterization of the Inflammatory Profile of Patients With Macrophage Activation Syndrome Secondary to Bacterial Sepsis (SAMOKINE)

The pathophysiology of macrophage activation syndrome has been mainly studied in pediatric genetic primary forms. There is little data in secondary forms related to bacterial sepsis. Because of the seriousness of this entity (43% of deaths in intensive care in the largest cohort published so far by the medical resuscitation team of Rouen University Hospital), it is necessary to better understand the physiopathological mechanisms to be able to propose a suitable therapy. For now, the management of this syndrome is far from consensual. Some authors advocate a single etiological treatment, while others suggest the need for intensive management of anti-inflammatory and immunosuppressive type. The fragility of resuscitation patients does not allow intensive immunosuppressive therapies as proposed by some authors. In the era of immunotherapy, the precise knowledge of physiopathological data would make it possible to propose a targeted therapy with little risk of adverse effects. Recent work has indeed shown excellent tolerance of immunotherapy during sepsis and could be applied eventually in patients with macrophage activation syndrome.

Study Overview

• Status: Unknown
• Conditions: Macrophage Activation Syndrome
• Intervention / Treatment: Biological: Blood samples

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patient hospitalized in intensive care for macrophage activation syndrome secondary to sepsis / bacterial septic shock with a strong clinical probability score (defined by a HScore> 80% cf appendix 4) (experimental population) or Patient hospitalized in intensive care for sepsis or septic shock (control population)

• Age ≥ 18 years
• Person affiliated with a social security scheme or beneficiary of such a scheme
• Trusted person or informed patient who has signed the consent to participate in the research. (If the patient is unable to sign his / her consent (emergencies) the consent will be signed by the person of trust, and consent to further study will be requested from the patient).
• Effective contraception in women of childbearing potential (negative pregnancy test). For postmenopausal women, a confirmation diagnosis should be obtained (amenorrhea for at least 12 months before the inclusion visit).

Exclusion Criteria:

• Pregnant or breastfeeding woman
• Person deprived of liberty by an administrative or judicial decision
• Protected major subject, under tutorship or curatorship
• Patient participating in another interventional clinical trial with the same primary objective

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: macrophage activation syndrome secondary to bacterial sepsis; Patients hospitalized in medical intensive care for macrophage activation syndrome secondary to bacterial sepsis	Biological: Blood samples; There are 3 specific blood sampling times for each patient, on D1, D2 and D5 (D1 being the day of inclusion): cytokine samples (IL-1β, IL-6, IL-10, TNF-α, IFN-gamma) on 5ml dry tube. On D1, a 2.5ml PAXgene tube will also be taken for each patient.
Other: bacterial sepsis/septic shock; Patients hospitalized in medical intensive care for sepsis / septic shock	Biological: Blood samples; There are 3 specific blood sampling times for each patient, on D1, D2 and D5 (D1 being the day of inclusion): cytokine samples (IL-1β, IL-6, IL-10, TNF-α, IFN-gamma) on 5ml dry tube. On D1, a 2.5ml PAXgene tube will also be taken for each patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quantitative measurement of plasma IL-1β in MAS patients secondary to septic sepsis / bacterial septic shock in comparison with a control population of sepsis /septic shock.	measured by the luminex method	performed on day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 30, 2018
• Last Update Submitted That Met QC Criteria: October 26, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Disease; Syndrome; Macrophage Activation Syndrome
• Other Study ID Numbers: 2017/185/HP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No