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

NCT05720728 | Completed

• 1 other identifier: 2419
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Candida Infection

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione PoliclinicoAgostino Gemelli IRCCS

Rome, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: May 14, 2019
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-01

Locations

IT (1)