Candida Infection2419NCT05720728
Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients
An observational study of Candida Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Candida Infection
- What is being tested?
- collection of blood samples
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 14 May 2019to 17 Feb 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients hospitalized one or more positive blood cultures for Candida spp, positive beta-glucanemia and the presence of at least one clinical symptom of infection will be considered cases of candidemia. Controls will be defined as patients at risk of candidaemia but with negative blood cultures and who have never started antifungal therapy in the 30 days following the date of the 1st blood culture. Patients at risk are defined as patients with fever who have at least two of the following factors: CVC, parenteral nutrition, antibiotic therapy in the previous 30 days for at least 7 days, abdominal surgery, polytrauma, dialysis, diabetes, at least two sites colonized by Candida.
Who may be able to join
- patients hospitalized
- one or more positive blood cultures for Candida spp,
- positive beta-glucanemia
- the presence of at least one clinical symptom of infection will be considered cases of candidemia.
Who cannot join
- age less than 18 years
- state of immunosuppression
- incompleteness of clinical data
- unavailability of serum samples in sufficient quantities for analysis and in good condition.
Trial locations and contacts
1 site in 1 country.
About this study
Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease
- Conditions
- Candida Infection
- Being tested
- collection of blood samples
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of blood samplesDiagnostic test
For each patient, a serum sample collected at the time when candidemia is suspected (time of execution of blood cultures) will be examined. For patients with candidemia, all serum samples taken during infection follow-up will also be examined.
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of antibodies
- presence and levels of antibodies directed towards beta-glucans and Candida virulence proteins. ii) presence and levels of circulating Candida virulence proteins. iii) presence and levels of soluble mediators of innate immunity and inflammation No genetic analysis will be performed.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start14 May 2019
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720728
- Sponsor's protocol ID
- 2419
- Acronym
- 2419
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05720728
- Acronym / sponsor ID
- 2419 / 2419
- Conditions
- Candida Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 9 Feb 2023 (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.
Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients hospitalized one or more positive blood cultures for Candida spp, positive beta-glucanemia and the presence of at least one clinical symptom of infection will be considered cases of candidemia. Controls will be defined as patients at risk of candidaemia but with negative blood cultures and who have never started antifungal therapy in the 30 days following the date of the 1st blood culture. Patients at risk are defined as patients with fever who have at least two of the following factors: CVC, parenteral nutrition, antibiotic therapy in the previous 30 days for at least 7 days, abdominal surgery, polytrauma, dialysis, diabetes, at least two sites colonized by Candida.
Key inclusion criteria (4 listed)
- patients hospitalized
- one or more positive blood cultures for Candida spp,
- positive beta-glucanemia
- the presence of at least one clinical symptom of infection will be considered cases of candidemia.
Key exclusion criteria (4 listed)
- age less than 18 years
- state of immunosuppression
- incompleteness of clinical data
- unavailability of serum samples in sufficient quantities for analysis and in good condition.
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 |
|---|---|---|
| collection of blood samplesFor each patient, a serum sample collected at the time when candidemia is suspected (time of execution of blood cultures) will be examined. For patients with candidemia, all serum samples taken during infection follow-up will also be examined. | Diagnostic test | – |
Primary outcome
levels of antibodies
Time frame: 1 year
i) presence and levels of antibodies directed towards beta-glucans and Candida virulence proteins. ii) presence and levels of circulating Candida virulence proteins. iii) presence and levels of soluble mediators of innate immunity and inflammation No genetic analysis will be performed.
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 13 Feb 2023.
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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 Candida Infection, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 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 13 Feb 2023. 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 Italy. 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?
levels of antibodies (time frame: 1 year). 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 13 Feb 2023.