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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT03136081

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock Candidiasis	Diagnostic Test: Candidiasis infection occurence

Detailed 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)

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Septic shock and candidiasis 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.	Diagnostic Test: Candidiasis infection occurence Candidiasis infection occurence

Arm

Intervention/Treatment

Septic shock and candidiasis

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.

Diagnostic Test: Candidiasis infection occurence

Candidiasis infection occurence

Outcome Measures

Primary Outcome Measures

Candidiasis infection occurence [Day 28 survival]
Outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)