CompletedNot Applicable

Candida Host Defense Response After Septic Shock in the Critically Ill

France50 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Candidiasis infection occurence

Timeframe: Day 28 survival

Trial details

NCT IDNCT03136081

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-05

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