NCT07422194

Brief Summary

Antimicrobial susceptibility testing (AST) of C. parapsilosis strains causing candidemia between 2018 and 2021 has shown a reduced susceptibility to azoles in general, with high rates of fluconazole resistance. This phenotypic profile is most expressed in C. parapsilosis strains; a profile that hasn't been frequently encountered in the past. According to several epidemiological studies, C. parapsilosis strains tend to show echinocandin resistance which drives us to believe that we are facing an outbreak that urges a thorough analysis of the resistances in question. We have activated a surveillance program to verify whether this episode is of an epidemic nature or rather a sporadic one. Our first concern is that of the emerging fluconazole resistance in C. parapsilosis, which could be attributed to the following phenomena:

  • A prolonged treatment with the antifungal in question,
  • The well documented point mutation in the ERG11 gene,
  • Over-expression of the CDR1 and MDR1 genes which encode for the activity of efflux pumps located on the fungal cell's membrane. We aimed to:
  • Study the incidence of various Candida species causing candidemia to design a local epidemiological framework.
  • Determine the most commonly isolated Candida species in BSIs to achieve a better understanding of their phenotypic and genotypic characteristics. This can aid in the choice of an appropriate antifungal treatment with a more accurate prediction of clinical outcomes.
  • Studying the potential of different Candida species to produce biofilm which can prove to be highly advantageous, especially in persistent Candida-related infections despite a targeted antifungal treatment.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

December 5, 2025

Last Update Submit

February 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Study the incidence of various Candida species causing candidemia to design a local epidemiological framework

    The absence of specific signs and symptoms of candidemia, their highly complex clinical pictures and high mortality - especially when the antimycotic treatment is delayed - calls for a need to develop more effective ways to counteract the problem. With few antifungal drugs available and increasing rates of antimycotic resistances, we believe that our efforts can improve the management of Candida-related BSIs.

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients with Candida spp. isolation in blood culture

You may qualify if:

  • adult patients older then 18 years old

You may not qualify if:

  • patients under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

Location

MeSH Terms

Conditions

TorulopsisCandidiasis, Invasive

Condition Hierarchy (Ancestors)

CandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal Infections
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 5, 2025

First Posted

February 19, 2026

Study Start

March 1, 2023

Primary Completion

October 30, 2024

Study Completion

December 30, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations