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

Sponsor

University Hospital, Rouen (Other)

Overall Status

Unknown status

CT.gov ID

NCT03721809

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macrophage Activation Syndrome	Biological: Blood samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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. [performed on day 1]
measured by the luminex method

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Rouen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT03721809

Other Study ID Numbers:

2017/185/HP

First Posted:

Oct 26, 2018

Last Update Posted:

Oct 30, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Macrophage Activation Syndrome

Syndrome

Study Results

No Results Posted as of Oct 30, 2018