Septic ShockIMMUNOCANDIDANCT03136081
Candida Host Defense Response After Septic Shock in the Critically Ill
An observational study of Septic Shock and Candidiasis, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock, Candidiasis
- What is being tested?
- Candidiasis infection occurence
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all consecutive patients subsequently to a septic shock with no Candida infection.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IMMUNOCANDIDA 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.
Read the 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
- Being tested
- Candidiasis infection occurence
- Keywords
- Septic shock, Candidiasis, Candidemia, Bacteremia, Immunoparalysis
- Medical subject headings
- Shock, Septic, Candidiasis, Candidemia, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Candidiasis infection occurenceDiagnostic test
Candidiasis infection occurence
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Candidiasis infection occurence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Candidiasis infection occurence
Outcome
Measured: Day 28 survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study startJun 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03136081
- Sponsor's protocol ID
- UF 9358
- Acronym
- IMMUNOCANDIDA
- Status last verified
- Apr 2017
- First submitted
- 27 Apr 2017
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMUNOCANDIDA Candida Host Defense Response After Septic Shock in the Critically Ill
- ClinicalTrials.gov ID
- NCT03136081
- Acronym / sponsor ID
- IMMUNOCANDIDA / UF 9358
- Conditions
- Septic Shock, Candidiasis
- Keywords
- Septic shock, Candidiasis, Candidemia, Bacteremia, Immunoparalysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic shock and candidiasis | – | Diagnostic Test: Candidiasis infection occurenceThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients subsequently to a septic shock with no Candida infection.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Candidiasis infection occurenceCandidiasis infection occurence | Diagnostic test | Septic shock and candidiasis |
Primary outcome
Candidiasis infection occurence
Time frame: Day 28 survival
Outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Candidiasis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Candidiasis infection occurence (time frame: Day 28 survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.