CandidaCANDI-PCRNCT04874441
Candida PCR Diagnosis Strategy in Patients From Intensive Care Units
A study testing Diagnosis strategy based on C. glabrata / krusei PCR in people with Candida, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida
- What is being tested?
- Diagnosis strategy based on C. glabrata / krusei PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2022to 14 Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient affiliated or benefiting from a social protection system
- Patient (or his/her trusted person) having given free and informed written consent to the investigating physician
- Non-neutropenic patient hospitalised in the Toulouse University Hospital intensive care unit.
- Patient with suspected invasive candidiasis for whom a blood culture for fungal infection diagnosis was taken and for whom an empirical treatment with echinocandin at an adapted dose was implemented.
Who cannot join
- Patients under guardianship or trusteeship, persons under court protection
- Pregnant or breastfeeding patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study
The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance of resistance and reducing the cost of antifungals for healthcare facilities.
Read the detailed description
Invasive candidiasis is a serious infection caused by yeasts of the genus Candida sp. Their incidence is increasing, particularly in intensive care. The prognosis is severe and depends on the early initiation of adequate antifungal treatment. At present, the diagnosis of invasive candidiasis is difficult since blood culture, the reference technique, has major limitations due to its low sensitivity, as well as very long delays in obtaining results. As a consequence, suspected invasive candidiasis is often treated empirically with echinocandins, resulting in the development of resistance and extremely high costs for health care facilities. The switch to treatments such as fluconazole is often delayed, although this molecule is effective on most Candida species except C. krusei and glabrata and is much less expensive than echinocandins.
For these reasons, the present study developed faster and more efficient methods to diagnose Candida krusei and glabrata species, based on the detection of DNA in the blood by PCR, allowing an earlier switch from echinocandins to Fluconazole.
The patients included will be divided into 2 groups: one group of patients will benefit from a diagnostic strategy based on blood culture (reference technique for the detection of Candida) and another group of patients will benefit from a diagnostic strategy based on this new PCR technique. The main objective will be to evaluate the effect of the PCR strategy on the time to obtain results and on the switch of antifungal agents. After inclusion, patients will be followed up at day 14, day 28 until discharge (or 3 months if the patient is still hospitalised).
- Conditions
- Candida
- Being tested
- Diagnosis strategy based on C. glabrata / krusei PCR
- Keywords
- candidemia, Polymerase Chain Reaction, DNA, antifungal agents
- Medical subject headings
- Torulopsis, Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis strategy based on C. glabrata / krusei PCRDiagnostic test
For diagnosis, a blood cultures and blood tubes for PCR will be collected and patients will be treated with echinocandins in the first instance with an early switch to fluconazole if the C. glabrata / krusei PCR is negative
| Study group | Role | What they receive |
|---|---|---|
| blood culture-based diagnostic strategy | No intervention | Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy |
| C. glabrata / krusei PCR diagnostic strategy | Experimental | Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a diagnostic strategy based on C. glabrata / krusei PCR Receives: Diagnostic Test: Diagnosis strategy based on C. glabrata / krusei PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reporting delay
the time (in hours) required for the results to be returned in relation to the time of sample collection
Measured: 14 days after blood sample taken
Secondary outcomes (1)
mortality at Day 28
Mortality rates will be taken 28 days after taking blood samples for Candida diagnosis in both groups
Measured: 28 days after blood sample taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start19 May 2022
- Primary completion14 Apr 2025
- Study completion14 Apr 2025
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 University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pamela CHAUVIN, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874441
- Sponsor's protocol ID
- RC31/19/0507
- Acronym
- CANDI-PCR
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2021
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study
- ClinicalTrials.gov ID
- NCT04874441
- Acronym / sponsor ID
- CANDI-PCR / RC31/19/0507
- Conditions
- Candida
- Keywords
- candidemia, Polymerase Chain Reaction, DNA, antifungal agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 14 Apr 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 5 May 2021 (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.
The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance of resistance and reducing the cost of antifungals for healthcare facilities.
Detailed description
Invasive candidiasis is a serious infection caused by yeasts of the genus Candida sp. Their incidence is increasing, particularly in intensive care. The prognosis is severe and depends on the early initiation of adequate antifungal treatment. At present, the diagnosis of invasive candidiasis is difficult since blood culture, the reference technique, has major limitations due to its low sensitivity, as well as very long delays in obtaining results. As a consequence, suspected invasive candidiasis is often treated empirically with echinocandins, resulting in the development of resistance and extremely high costs for health care facilities. The switch to treatments such as fluconazole is often delayed, although this molecule is effective on most Candida species except C. krusei and glabrata and is much less expensive than echinocandins.
For these reasons, the present study developed faster and more efficient methods to diagnose Candida krusei and glabrata species, based on the detection of DNA in the blood by PCR, allowing an earlier switch from echinocandins to Fluconazole.
The patients included will be divided into 2 groups: one group of patients will benefit from a diagnostic strategy based on blood culture (reference technique for the detection of Candida) and another group of patients will benefit from a diagnostic strategy based on this new PCR technique. The main objective will be to evaluate the effect of the PCR strategy on the time to obtain results and on the switch of antifungal agents. After inclusion, patients will be followed up at day 14, day 28 until discharge (or 3 months if the patient is still hospitalised).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blood culture-based diagnostic strategy | No intervention | –Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy |
| C. glabrata / krusei PCR diagnostic strategy | Experimental | Diagnostic Test: Diagnosis strategy based on C. glabrata / krusei PCRPatients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a diagnostic strategy based on C. glabrata / krusei PCR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient affiliated or benefiting from a social protection system
- Patient (or his/her trusted person) having given free and informed written consent to the investigating physician
- Non-neutropenic patient hospitalised in the Toulouse University Hospital intensive care unit.
- Patient with suspected invasive candidiasis for whom a blood culture for fungal infection diagnosis was taken and for whom an empirical treatment with echinocandin at an adapted dose was implemented.
Key exclusion criteria (2 listed)
- Patients under guardianship or trusteeship, persons under court protection
- Pregnant or breastfeeding patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis strategy based on C. glabrata / krusei PCRFor diagnosis, a blood cultures and blood tubes for PCR will be collected and patients will be treated with echinocandins in the first instance with an early switch to fluconazole if the C. glabrata / krusei PCR is negative | Diagnostic test | C. glabrata / krusei PCR diagnostic strategy |
Primary outcome
Reporting delay
Time frame: 14 days after blood sample taken
the time (in hours) required for the results to be returned in relation to the time of sample collection
1 secondary outcome
mortality at Day 28
Time frame: 28 days after blood sample taken
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
Pamela CHAUVIN, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis strategy based on C. glabrata / krusei PCR in people with Candida, run by University Hospital, Toulouse at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 Aug 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reporting delay (time frame: 14 days after blood sample taken). 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 11 Aug 2026.