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

Macrophage Activation Syndrome Clinical Trial

— SAMOKINE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03721809
• Other study ID #: 2017/185/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: December 2020

Study information

• Verified date: October 2018
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macrophage Activation Syndrome
• Syndrome

Intervention

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-1ß, IL-6, IL-10, TNF-a, IFN-gamma) on 5ml dry tube. On D1, a 2.5ml PAXgene tube will also be taken for each patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantitative measurement of plasma IL-1ß 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