Critical IllnessCandigeneNCT02888860
Innate Immunity Gene Polymorphisms and Yeast Colonization
An observational study of Critical Illness, run by University Hospital, Lille at 6 sites in France.
Trial summary
It is proposed to carry out the study in three medical or surgical intensive care units (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will be taken for genotyping of the lectins MBL… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 2,200 participants
- Where
- 6 sitesFrance
- Study dates
- 3 Jan 2013to 3 Jan 2021
- How long will I take part?
- 15 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- Male or female patients, ≥18 years of age, admitted to medical or surgical ICU for a duration of >48 h, irrespective of their colonisation status.
Who cannot join
- -Patient (or their representative) who refuses to participate in the study or to undergo the procedures required for the investigations (mycological sampling in order to determine the CIC, blood sampling for genotyping of DNA and for serology)
- Previous antifungal treatment (in the 15 days preceding admission to the ICU).
- A CIC value based on an insufficient number of sampled sites (<6).
- Neutropenic patients
- Patients who are receiving immunosuppressants (transplanted, grafted...)
- Patients who do not have universal cover or Social Security cover
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre hospitalier
Arras
Centre hosptialier
Boulogne-sur-Mer
CH Schaffner
Lens
CHRU de Lille
Lille, Nord, 59037
Hôpital Saint-Philibert
Lomme
CH Victor Provo
Roubaix
About this study
Official title: Analysis of TLRs and Lectin Gene Polymorphisms. Impact on Yeast Colonization in Hospitalized Patients and on Adaptive Response Against Yeast Glycans
It is proposed to carry out the study in three medical or surgical intensive care units (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will be taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be assessed in all patients (according to the CIC), and antibodies to yeast glycans will be determined by a simultaneous multiparametric analysis involving several families of natural or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).
Read the detailed description
Determination of the CIC:
The CIC will be determined on admission and then once a week during hospitalisation. This will be carried out on a fixed day for all patients; we will avoid determining the CIC any closer than 2 days apart. It is not planned in this study to modify the therapeutic strategy of the ICU services. The strains isolated will be stored in glycerol solution at -80°C. The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory.
Genotyping of lectin genes and TLRs:
Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA
Serological study, detection of antibodies to yeast glycans:
10 ml of whole blood will be taken from each patient on the day of inclusion and over the duration of hospitalisation (maximum total quantity of 40 ml). This will be done on a fixed day for all patients; we will avoid sampling any closer than 2 days apart.
Functional tests on peripheral blood mononuclear cells (PBMCs) Taking into account the fact that the results of genotyping will not be available in real time and the need to work with freshly collected cells, a group size of 50 patients in group 2 (negative CIC over the duration of hospitalisation) and 50 patients in group 3 (negative CIC at admission but positive at hospital discharge) will be analysed.
Stimulation tests will be carried out in the presence of whole yeasts or yeast extracts on sub-populations of cells isolated from 20 ml of peripheral blood in EDTA.
- Conditions
- Critical Illness
- Keywords
- genetic susceptibility, candida infection, colonization
- Medical subject headings
- Critical Illness, Genetic Predisposition to Disease, Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with candidemia | |
| Group 2 | Patients without colonization during follow up | |
| Group 3 | Patients without colonization at admission, with subsequent colonization during hospitalization | |
| Group | Patients colonized at admission, and during the whole hospitalization | |
| Group 5 | Patients who develop colonization during hospitalization and become negative at discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of polymorphisms
the frequency is measured for the association between the presence of a polymorphism and colonization by Candida sp.
frequency of polymorphisms at least one lectin gene or TLRs between some colonized patients (G5) and the non-colonized patients (G2).
Measured: From date of inclusion until the last day hospital stay (at once a week)
Secondary outcomes (3)
Genotyping of lectin genes and toll-like-receptors (TLRs)
The analysis relates to genetic factors already described for lectins and will also include variants of genes involved in innate immunity host-microorganism interactions such as TLRs
Measured: From date of inclusion until the last day hospital stay (at once a week)
Colonization index
This index is calculated for each patient at the entrance of the service and then once a week until discharge (at least two weeks after admission). This index is the ratio between the number of body sites colonized heavily on the number of body sites explored when at least one colony of Candida spp. was observed.
The determination of Candida colonization index requires the implementation of several samples from different body sites. The sampled anatomical sites concern
- mouth (oropharyngeal swab)
- stomach (gastric aspiration)
- trachea (tracheal suctioning)
- urine
- rectum (rectal swab or stool).
Measured: at admission and weekly for at least two weeks after.
Functional tests on peripheral blood mononuclear cells (PBMC)
Functional tests on peripheral blood mononuclear cells (PBMC) obtained from mutated patients for given Innate-immunity genes will be carried out through stimulation tests in the presence of whole yeast or derived-molecules on isolated cell subpopulations.
Measured: at admission and weekly for at least two weeks after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start3 Jan 2013
- Primary completion3 Jan 2021
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Daniel Mathieu, Prof, Principal investigator, CHRU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888860
- Sponsor's protocol ID
- 2011_33
- Other IDs
- 2011_33, 2012-A00485-38
- Acronym
- Candigene
- Status last verified
- Aug 2020
- First submitted
- 28 Feb 2014
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of TLRs and Lectin Gene Polymorphisms. Impact on Yeast Colonization in Hospitalized Patients and on Adaptive Response Against Yeast Glycans
- ClinicalTrials.gov ID
- NCT02888860
- Acronym / sponsor ID
- Candigene / 2011_33
- Conditions
- Critical Illness
- Keywords
- genetic susceptibility, candida infection, colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
It is proposed to carry out the study in three medical or surgical intensive care units (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will be taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be assessed in all patients (according to the CIC), and antibodies to yeast glycans will be determined by a simultaneous multiparametric analysis involving several families of natural or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).
Detailed description
Determination of the CIC:
The CIC will be determined on admission and then once a week during hospitalisation. This will be carried out on a fixed day for all patients; we will avoid determining the CIC any closer than 2 days apart. It is not planned in this study to modify the therapeutic strategy of the ICU services. The strains isolated will be stored in glycerol solution at -80°C. The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory.
Genotyping of lectin genes and TLRs:
Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA
Serological study, detection of antibodies to yeast glycans:
10 ml of whole blood will be taken from each patient on the day of inclusion and over the duration of hospitalisation (maximum total quantity of 40 ml). This will be done on a fixed day for all patients; we will avoid sampling any closer than 2 days apart.
Functional tests on peripheral blood mononuclear cells (PBMCs) Taking into account the fact that the results of genotyping will not be available in real time and the need to work with freshly collected cells, a group size of 50 patients in group 2 (negative CIC over the duration of hospitalisation) and 50 patients in group 3 (negative CIC at admission but positive at hospital discharge) will be analysed.
Stimulation tests will be carried out in the presence of whole yeasts or yeast extracts on sub-populations of cells isolated from 20 ml of peripheral blood in EDTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with candidemia |
| Group 2 | – | –Patients without colonization during follow up |
| Group 3 | – | –Patients without colonization at admission, with subsequent colonization during hospitalization |
| Group | – | –Patients colonized at admission, and during the whole hospitalization |
| Group 5 | – | –Patients who develop colonization during hospitalization and become negative at discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (1 listed)
- Male or female patients, ≥18 years of age, admitted to medical or surgical ICU for a duration of >48 h, irrespective of their colonisation status.
Key exclusion criteria (6 listed)
- -Patient (or their representative) who refuses to participate in the study or to undergo the procedures required for the investigations (mycological sampling in order to determine the CIC, blood sampling for genotyping of DNA and for serology)
- Previous antifungal treatment (in the 15 days preceding admission to the ICU).
- A CIC value based on an insufficient number of sampled sites (<6).
- Neutropenic patients
- Patients who are receiving immunosuppressants (transplanted, grafted...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of polymorphisms
Time frame: From date of inclusion until the last day hospital stay (at once a week)
the frequency is measured for the association between the presence of a polymorphism and colonization by Candida sp. frequency of polymorphisms at least one lectin gene or TLRs between some colonized patients (G5) and the non-colonized patients (G2).
3 secondary outcomes
Genotyping of lectin genes and toll-like-receptors (TLRs)
Time frame: From date of inclusion until the last day hospital stay (at once a week)
Colonization index
Time frame: at admission and weekly for at least two weeks after.
Functional tests on peripheral blood mononuclear cells (PBMC)
Time frame: at admission and weekly for at least two weeks after.
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 4 Nov 2022.
Related trials for Critical Illness
Not yet recruiting
Family-partnered Delirium Prevention, Detection, and Management in the ICU
Delirium, Intensive Care Unit Delirium
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
Not yet recruitingObservational study
Dynamic Inflammatory Changes and Nutritional Risk Scores in ICU Patients Aged 65 Years and Older
Critical Illness, Geriatric Patient
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.
Daniel Mathieu, Prof principal investigator
CHRU de Lille
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University Hospital, Lille at 6 sites 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 1 inclusion and 6 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Frequency of polymorphisms (time frame: From date of inclusion until the last day hospital stay (at once a week)). 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 4 Nov 2022.