Candida Host Defense Response After Septic Shock in the Critically Ill

Septic Shock Clinical Trial

— IMMUNOCANDIDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136081
• Other study ID #: UF 9358
• Status: Completed
• Phase: N/A
• First received: April 27, 2017
• Last updated: April 27, 2017
• Start date: June 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2017
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Candidiasis
• Critical Illness
• Septic Shock
• Shock
• Shock, Septic

Intervention

Diagnostic Test:
• Candidiasis infection occurence
Candidiasis infection occurence

Locations

Country	Name	City	State
France	Hôpital St Eloi	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Candidiasis infection occurence	Outcome	Day 28 survival