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

Completed

• Conditions: Candida Infection

• Registration Number: NCT05720728
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-14
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-17
• Status Verified: 2023-01
• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
levels of antibodies	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.

Trial Locations

Locations (1)

Fondazione PoliclinicoAgostino Gemelli IRCCS; 🇮🇹 Rome, Roma, Italy