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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Completed
CT.gov ID
NCT05720728
Collaborator
(none)
50
Enrollment
1
Location
33.2
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: collection of blood samples

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Research of New Serological Markers for the Diagnosis and Monitoring of Candidaemia in Hospitalized Patients
Actual Study Start Date :
May 14, 2019
Actual Primary Completion Date :
Feb 17, 2022
Actual Study Completion Date :
Feb 17, 2022

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione PoliclinicoAgostino Gemelli IRCCS Rome Roma Italy 00168

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05720728
Other Study ID Numbers:
  • 2419
First Posted:
Feb 9, 2023
Last Update Posted:
Feb 13, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Candidemia
Candidiasis

Study Results

No Results Posted as of Feb 13, 2023