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

Candida Infection Clinical Trial

— 2419  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05720728
• Other study ID #: 2419
• Status: Completed
• Start date: May 14, 2019
• Est. completion date: February 17, 2022

Study information

• Verified date: January 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Candida Infection
• Candidemia
• Candidiasis

Intervention

Diagnostic Test:
• collection of blood samples
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.

Locations

Country	Name	City	State
Italy	Fondazione PoliclinicoAgostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of antibodies	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.	1 year