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Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05720728
Acronym
2419
Enrollment
50
Registered
2023-02-09
Start date
2019-05-14
Completion date
2022-02-17
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candida Infection

Brief 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. 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

Interventions

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
levels of antibodies1 yeari) 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026