Candida Host Defense Response After Septic Shock in the Critically Ill (IMMUNOCANDIDA)

University Hospital Center (CHU)

Status: Completed

Conditions: Candidiasis; Septic Shock

Treatments: Diagnostic Test: Candidiasis infection occurence

Study type: Observational

Funder types: Other

Identifiers

NCT03136081

UF 9358

Details and patient eligibility

About

Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.

Full description

Single center prospective observationnal study. Inclusion: all consecutive patients subsequently to a septic shock with no Candida infection.

Measured parameters: host response (HLADR, CD64, inflammatory cytokines consecutive to LPS exposition) and Candida biomarkers (beta D Glucan, Mannan Ag and Ig), demographics, outcome (occurence of Candida nosocomial infection, morbidity and survival)

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Age > = 18 years

• The patients in toxic shock defined according to the Bone criteria
• Informed consent of the patient or his reliable person (poursuit consent in this case). Possibility of inclusion according to the emergency procedure with the obligation of research for the consent with the reliable person and with the patient.
• Obligation of membership or beneficiary to have a national insurance

Exclusion criteria

• Pregnant or breast-feeding women according to the article L1121-5 of the CSP
• Vulnerable people according to the article L1121-6 of the CSP 9358 _ "
• Neutropénie 500 / mm3
• Infection by the HIV, the hepatitis C or B active column
• Biotherapics (anti-CD20, anti-TNFa, anti-IL-6)
• Treatments immunosuppresseurs (methotrexate, azathioprine, cyclophosphamide, mycophenolate mofétil, cyclosporine, tacrolimus)
• Corticosteroid therapy = 1mg / kg of equivalent prednisone for more than a month
• Toxic shock due to a deep candidiasis in the admission in resuscitation
• Congenital deficits of Th17 (cutanéo-mucous candidiasis chronicles, syndrome of hyper IgE)

Trial design

50 participants in 1 patient group

Septic shock and candidiasis

Description:

The realized analyses will be two types: 1/an immunological analysis that is the characterization of the capacities of defense against germs and 2/a search(research) of Candida by microscopic examination and culture on circles of growth but also the research for the genome of the mushroom by a state-of-the-art technique of the laboratory of mycology ( PCR). Usual takings of research for bacteria.

Treatment:

Diagnostic Test: Candidiasis infection occurence