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Completed

NCT Number: NCT03136081

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.

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Key information

Conditions

Septic Shock Bacteremia Bacterial Infections Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital St Eloi

Montpellier, 34295, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Candidiasis infection occurence

Diagnostic Test

Candidiasis infection occurence

Primary outcomes

  1. Candidiasis infection occurence

    Time frame: Day 28 survival

    Outcome

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: IMMUNOCANDIDA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 2, 2017
Registry last updated
May 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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