Skip to main content
OpenTrials
Completed

NCT Number: NCT05720728

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Candida Infection Bacterial Infections and Mycoses Candidiasis Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione PoliclinicoAgostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of Blood samples

Diagnostic 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: 2419

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2023
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.