Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients (2419)

February 9, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione PoliclinicoAgostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2019

Primary Completion (ACTUAL)

February 17, 2022

Study Completion (ACTUAL)

February 17, 2022

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 9, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2419

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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