- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422194
Phylogenetic Characteristics of Different Candida Species and Their Impact on the Clinical Picture of Patients With Invasive Candidiasis. What Has Changed During the COVID Pandemic?
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.
Study Overview
Status
Conditions
Study Type
Contacts and Locations
Study Locations
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Pavia
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Pavia, Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo di Pavia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
adult patients older then 18 years old
Exclusion Criteria:
patients under 18 years old
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Study the incidence of various Candida species causing candidemia to design a local epidemiological framework
Time Frame: 24 months
|
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.
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24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p_57
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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