Candida Host Defense Response After Septic Shock in the Critically Ill

Completed

• Conditions: Septic Shock; Candidiasis
• Interventions: Diagnostic Test: Candidiasis infection occurence

• Registration Number: NCT03136081
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2017-04
• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Last Update Submitted: 2017-04-27
• Study First Posted: 2017-05-02
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic shock and candidiasis	Candidiasis infection occurence	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.

Primary Outcome Measures

Name	Time	Method
Candidiasis infection occurence	Day 28 survival	Outcome

Trial Locations

Locations (1)

Hôpital St Eloi; 🇫🇷 Montpellier, France