Invasive CandidiasisNCT02841501
Genetic Susceptibility Factors for Candidemia.
An observational study of Invasive Candidiasis and Candidemia, run by University Hospital, Lille at 1 site in France.
Trial summary
This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis, Candidemia, Genetic Predisposition to Disease
- What is being tested?
- Analysis of genetic polymorphisms
- How many people
- 453 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to 25 Jun 2020
- 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: Hospitalized patients exhibiting a positive blood culture with isolation of Candida sp.
Who may be able to join
- Patient older than 18 years.
- Informed consent.
- Positive blood culture with isolation of Candida sp.
Who cannot join
- No informed consent.
- Patient younger than 18.
- No insurance coverage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.
This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.
- Being tested
- Analysis of genetic polymorphisms
- Keywords
- Gene Expression Profiling, Genome-Wide Association Study, Polymorphism, Single Nucleotide, Drug Resistance, Fungal
- Medical subject headings
- Candidiasis, Invasive, Candidemia, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of genetic polymorphismsGenetic
An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.
| Study group | Role | What they receive |
|---|---|---|
| Candidemia patients | These patients are included in the study after the reception of a positive blood culture for Candida sp. Receives: Genetic: Analysis of genetic polymorphisms | |
| Control patients | These patients are matched on case patients on the following criteria:
* Age+/-5 years
* length of hospitalisation
* type of ward
* type of surgery for surgical patients
* IGS2 for intensive care patients Receives: Genetic: Analysis of genetic polymorphisms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of the polymorphisms between the groups
Measured: In the 48-72 hours following the positive blood culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJun 2013
- Primary completion25 Jun 2020
- Study completion25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Seventh Framework Programme, University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Julien Poissy, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841501
- Sponsor's protocol ID
- 2011_63
- Other IDs
- 2012-A01344-39
- Status last verified
- Aug 2020
- First submitted
- 20 Jul 2016
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Susceptibility Factors Involved in Candidemia: Case-control Study.
- ClinicalTrials.gov ID
- NCT02841501
- Acronym / sponsor ID
- 2011_63
- Keywords
- Gene Expression Profiling, Genome-Wide Association Study, Polymorphism, Single Nucleotide, Drug Resistance, Fungal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Seventh Framework Programme, University of Lausanne Hospitals
- Study start
- Jun 2013 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 25 Jun 2020 (actual)
- First posted
- 22 Jul 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.
This is a prospective case-control physiopathological study, which main objective is to determine the genetic host factors predisposing to candidemia. Secondary objectives are to develop new diagnosis tools using the biological collection, to describe and update epidemiology, to analyse the influence of genetic polymorphisms on prognosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candidemia patients | – | Genetic: Analysis of genetic polymorphismsThese patients are included in the study after the reception of a positive blood culture for Candida sp. |
| Control patients | – | Genetic: Analysis of genetic polymorphismsThese patients are matched on case patients on the following criteria: * Age+/-5 years * length of hospitalisation * type of ward * type of surgery for surgical patients * IGS2 for intensive care patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients exhibiting a positive blood culture with isolation of Candida sp.
Key inclusion criteria (3 listed)
- Patient older than 18 years.
- Informed consent.
- Positive blood culture with isolation of Candida sp.
Key exclusion criteria (3 listed)
- No informed consent.
- Patient younger than 18.
- No insurance coverage.
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 |
|---|---|---|
| Analysis of genetic polymorphismsAn analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study. | Genetic | Candidemia patients, Control patients |
Primary outcome
Frequency of the polymorphisms between the groups
Time frame: In the 48-72 hours following the positive blood culture
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 26 Mar 2021.
- 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.
Julien Poissy, MD, PhD principal investigator
University Hospital, Lille
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 Invasive Candidiasis and Candidemia, run by University Hospital, Lille 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 3 inclusion and 3 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 26 Mar 2021. 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?
Frequency of the polymorphisms between the groups (time frame: In the 48-72 hours following the positive blood culture). 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 26 Mar 2021.