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

NCT03721809 | Completed

• 1 other identifier: 2017/185/HP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Macrophage Activation Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

macrophage activation syndrome secondary to bacterial sepsis

OTHER

Patients hospitalized in medical intensive care for macrophage activation syndrome secondary to bacterial sepsis

Biological: Blood samples

bacterial sepsis/septic shock

OTHER

Patients hospitalized in medical intensive care for sepsis / septic shock

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

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.

bacterial sepsis/septic shock; macrophage activation syndrome secondary to bacterial sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

CHU Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Macrophage Activation Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: March 21, 2019
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

FR (1)