ClinicalTrials.gg
CompletedNCT04874441CANDI-PCRUpdated Aug 11, 2026

Candida PCR Diagnosis Strategy in Patients From Intensive Care Units

An interventional study of Diagnosis strategy based on C. glabrata / krusei PCR in Candida, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Candidemia with a site in France — 1 open to participants now, 1 under way, 1 of them phase 3. Candidemia · France.

Enrollment
9th of 10
48 · median 208
Started
2022
with 1 other
No phase
Only one
of the 16
Registered
13th of 16
by date

Among the 16 studies in Candidemia with a site in France, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2022, is the only one with no phase, and was the 13th registered.

Candidemia

73 studies on the registry are indexed under Candidemia; 5 are open to participants now.

Browse Candidemia studies →

Open to participants now

1 of the 16 studies in Candidemia with a site in France is open now. Recruiting first, the newest first:

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 2 Candidemia studies recruiting now, 2 (100%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Candidemia with a site in France, or all of them as a file.
02

Study 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. 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).

03

Conditions studied

  • Candida

Browse trials for

Keywords

  • candidemia
  • Polymerase Chain Reaction
  • DNA
  • antifungal agents
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship or trusteeship, persons under court protection
  • Pregnant or breastfeeding patients.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • No intervention
    blood culture-based diagnostic strategy

    Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy

  • Experimental
    C. glabrata / krusei PCR diagnostic strategy

    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

    Diagnostic Test: Diagnosis strategy based on C. glabrata / krusei PCR

Interventions

  • Diagnostic testDiagnosis strategy based on C. glabrata / krusei PCR

    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

06

What researchers measure

Primary outcomes

  1. Reporting delay

    the time (in hours) required for the results to be returned in relation to the time of sample collection

    Time frame: 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

    Time frame: 28 days after blood sample taken

07

Study locations

1 site
  • Uh Toulouse
    Toulouse, Occitanie 31000, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Apr 2025, 34 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2021
First posted
May 5, 2021
StartActual
May 19, 2022
Primary completionActual
Apr 14, 2025
CompletionActual
Apr 14, 2025
Last update
Aug 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04874441
Responsible party
Sponsor
First posted
May 5, 2021
Start date
May 19, 2022
Primary completion
Apr 14, 2025
Completion
Apr 14, 2025
Last update
Aug 11, 2026

Study contacts

Pamela CHAUVIN, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion