Candida Host Defense Response After Septic Shock in the Critically Ill

NCT ID: NCT03136081

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-05-31

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)

Conditions

Septic Shock; Candidiasis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Candidiasis infection occurence

Intervention Type: DIAGNOSTIC_TEST

Candidiasis infection occurence

Interventions

Candidiasis infection occurence

Candidiasis infection occurence

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital St Eloi

Montpellier, , France

Countries

France

Other Identifiers

UF 9358

Identifier Type: -

Identifier Source: org_study_id