Candida Host Defense Response After Septic Shock in the C... | NCT03136081

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

NCT03136081

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

May 2, 2017Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Septic Shock
Candidiasis

Interventions

Candidiasis infection occurence

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014Actual

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Apr 27, 2017

First Submission Date that Met QC Criteria

Apr 27, 2017

First Posted Date

May 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2017

Last Update Posted Date

May 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Candidiasis infection occurence	Diagnostic Test	Candidiasis infection occurence	Septic shock and candidiasis

Measure	Description	Time Frame
Candidiasis infection occurence	Outcome	Day 28 survival

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital St Eloi		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D002177	Candidiasis
D058387	Candidemia
D016470	Bacteremia

Ancestor Terms

ID	Term
D018805	Sepsis
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation

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