CandidaNCT07422194
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?
An observational study of Candida and Candida Systemic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida, Candida Systemic, Blood
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with Candida spp. isolation in blood culture
Who may be able to join
- adult patients older then 18 years old
Who cannot join
- patients under 18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, 27100
About this study
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:
Read more
- 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.
- Conditions
- Candida, Candida Systemic, Blood
- Medical subject headings
- Torulopsis, Candidiasis, Invasive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: Only strains were analysed, not patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caterina Cavanna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422194
- Sponsor's protocol ID
- p_57
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT07422194
- Acronym / sponsor ID
- p_57
- Conditions
- Candida, Candida Systemic, Blood
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Only strains were analysed, not patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with Candida spp. isolation in blood culture
Key inclusion criteria (1 listed)
- adult patients older then 18 years old
Key exclusion criteria (1 listed)
- patients under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candida and Candida Systemic, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the incidence of various Candida species causing candidemia to design a local epidemiological framework (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.