CandidemiaNCT02333266
Bio-assay Development and Implementation for Fungal Infection Detection
An observational study of Candidemia, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Candidemia
- What is being tested?
- Candidemia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Dec 2017
- 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 laying in the hospital that suffer from a candidemia.
Who may be able to join
- Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
- Candidemia
Who cannot join
- None
About this study
The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.
Read the detailed description
The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.
- Conditions
- Candidemia
- Being tested
- Candidemia
- Keywords
- Candida bloodstream infection, Detection fungal cells, Fiber-Optic Surface Plasmon Resonance (FO-SPR)
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandidemiaOther
| Study group | Role | What they receive |
|---|---|---|
| Candidemia | 0 Receives: Other: Candidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
Patients in the hospital and suspected to have a Candida infection will be tested for Candida infections via blood cultures. Blood samples for patients with a positive test will be taken immediately after the positive result and used to validate the FUNGDETECT sensor.
Measured: Blood samples will be collected at baseline from patients directly after informed consent is given
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
Why it stopped: The bioassay development is too difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeroen Lammertyn, Prof., Study director, KU LeuvenKatrien Lagrou, Prof., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333266
- Sponsor's protocol ID
- S57146
- Status last verified
- Dec 2015
- First submitted
- 17 Dec 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-assay Development and Implementation for Fungal Infection Detection
- ClinicalTrials.gov ID
- NCT02333266
- Acronym / sponsor ID
- S57146
- Conditions
- Candidemia
- Keywords
- Candida bloodstream infection, Detection fungal cells, Fiber-Optic Surface Plasmon Resonance (FO-SPR)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The bioassay development is too difficult.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- First posted
- 7 Jan 2015 (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.
The purpose of this study is to determine whether the newly developed biosensor can be used to detect and quantify fungal cells in human blood samples.
Detailed description
The study discussed here is part of a broader research project (IOF project) that is aimed at the development and implementation of a point-of-care devices, in which Fiber-Optic Surface Plasmon Resonance (FO-SPR) is used as a detection system. This project includes the development and implementation of the (FUNGDETECT) sensor for fast and accurate detection of fungal pathogens in human blood samples. In first instance, the sensor will be tested in buffer solutions spiked with a known amount of Candida albicans cells. Further validation of the prototype includes detection of these cells in human blood samples. In a first experiment, detection of yeast cells will be performed in blood samples from 5 healthy volunteers each spiked with yeast cells from different Candida spp.. A second experiment includes the detection in blood samples from 15 patients who suffer from a candidemia. The blood samples will be collected from patients of University Hospitals (UZ) Leuven.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidemia | – | Other: Candidemia0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients laying in the hospital that suffer from a candidemia.
Key inclusion criteria (2 listed)
- Healthy volunteers for validation of the (FUNGDETECT) sensor (Spiked blood samples)
- Candidemia
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Candidemia | Other | Candidemia |
Primary outcome
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans
Time frame: Blood samples will be collected at baseline from patients directly after informed consent is given
Patients in the hospital and suspected to have a Candida infection will be tested for Candida infections via blood cultures. Blood samples for patients with a positive test will be taken immediately after the positive result and used to validate the FUNGDETECT sensor.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
Related trials for Candidemia
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
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A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
Candidemia
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.
Jeroen Lammertyn, Prof. study director
KU Leuven
Katrien Lagrou, Prof. principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia, run by Universitaire Ziekenhuizen KU Leuven.
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 1 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: withdrawn, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Detection of Candida albicans with the newly developed FUNGDETECT sensor in blood samples from patients with candidemia due to Candida albicans (time frame: Blood samples will be collected at baseline from patients directly after informed consent is given). 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 12 May 2016.