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

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

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock; Candidiasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Hôpital St Eloi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all consecutive patients subsequently to a septic shock with no Candida infection.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Candidiasis infection occurence	Outcome	Day 28 survival

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (ACTUAL): May 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Bacteremia; Septic shock; Candidiasis; Candidemia; Immunoparalysis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Mycoses; Shock, Septic; Candidiasis; Shock
• Other Study ID Numbers: UF 9358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No