CandidiasisNCT01919931
Immunological Interaction Between the Host and Candida Albicans Biofilm
An observational study of Candidiasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Candidiasis
- How many people
- 237 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Jan 2016
- 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: Patients with Candida albicans infection. Patients with no Candida albicans infection. Healthy volunteers
Who may be able to join
- Patients infected with Candida albicans
- Patients not infected with Candida albicans
Who cannot join
- Underage patients
- Non consenting patients
- Unconscious patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunological and Molecular Interaction Between the Host and Candida Albicans Biofilm
Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.
- Conditions
- Candidiasis
- Keywords
- Candida albicans, Candidiasis, Biofilm, Flow cytometry, Mannose Binding Lectin
- Medical subject headings
- 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 |
|---|---|---|
| Candida Infection | Patients infected with Candida albicans | |
| No infection | Patients with no Candida albicans infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological phenotyping of patients
Measured: 2 months
Secondary outcomes (1)
Mannose Binding Lectin levels
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adrian Liston, Group Leader, Study director, Flemish Institute of Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919931
- Sponsor's protocol ID
- S55012
- Status last verified
- Dec 2016
- First submitted
- 19 Jun 2013
- Last updated
- 7 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological and Molecular Interaction Between the Host and Candida Albicans Biofilm
- ClinicalTrials.gov ID
- NCT01919931
- Acronym / sponsor ID
- S55012
- Conditions
- Candidiasis
- Keywords
- Candida albicans, Candidiasis, Biofilm, Flow cytometry, Mannose Binding Lectin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 9 Aug 2013 (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.
Candida albicans is one of the most common nosocomial infection and the onset relies on the host immune status. The purpose of this study is to determine the immunological profile of patients infected with Candida albicans, that could ideally lead to a strategy to identify patients who could benefit from prophylaxis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candida Infection | – | –Patients infected with Candida albicans |
| No infection | – | –Patients with no Candida albicans infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Candida albicans infection. Patients with no Candida albicans infection. Healthy volunteers
Key inclusion criteria (2 listed)
- Patients infected with Candida albicans
- Patients not infected with Candida albicans
Key exclusion criteria (3 listed)
- Underage patients
- Non consenting patients
- Unconscious patients
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
Immunological phenotyping of patients
Time frame: 2 months
1 secondary outcome
Mannose Binding Lectin levels
Time frame: 1 month
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 7 Dec 2016.
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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.
Adrian Liston, Group Leader study director
Flemish Institute of Biotechnology
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 Candidiasis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 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 7 Dec 2016. 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 Belgium. 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?
Immunological phenotyping of patients (time frame: 2 months). 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 7 Dec 2016.