Candida Auris InfectionDiagRaMIE CaurNCT07253311
Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris
An observational study of Candida Auris Infection and Candida Auris Colonization, run by Assistance Publique - Hôpitaux de Paris at 1 site in Greece.
Trial summary
"Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida Auris Infection, Candida Auris Colonization, Nosocomial Infections
- What is being tested?
- NG-TestⓇ C.auris kit
- How many people
- 554 participants
- Where
- 1 siteGreece
- Study dates
- 25 May 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population includes hospitalized patients suspected of Candida auris infection or cutaneous colonization.
Who may be able to join
- From patients with suspected Candida auris infection:
- All isolates from the population that grow on the selective media: Sabouraud-dextrose (40g/L dextrose, 5.0g/L of peptic digest of animal tissue, 5.0 g/L of pancreatic digest of casein, 15.0 g/L of agar and final pH 5.6 ± 0.2) and CHROMagar™ Candida plus (manufactured by CHROMagar™, France). used in the hospital's routine diagnostic process.
- From patients with suspected Candida auris cutaneous colonization:
- All isolates from the population that grow on the selective media: Salt-Sabouraud Dulcitol Broth (SSDB) with chloramphenicol and gentamicin (manufactured by S2 Media, United States), And the media used in the hospital's routine diagnostic process: Sabouraud Dextrose Liquid Medium containing NaCl 10%, chloramphenicol 50 mg/L.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris DiagRaMIE C AURIS
"Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings.
This study aims to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech. The test uses immunochromatography and can detect Candida auris in about 15 minutes. Its results will be compared to the reference method, MALDI-TOF, performed on colonies grown from routine patient samples.
Both retrospective (using stored isolates) and prospective (using new isolates) evaluations will be conducted. The study will measure the sensitivity and specificity of the test, and also include an assessment of its ease of use by laboratory staff. No additional samples will be collected from patients, and all testing will use de-identified isolates to ensure confidentiality."
Read the detailed description
This monocentric, non-randomized diagnostic accuracy study aims to evaluate the NG-Test® Candida auris, a lateral flow immunoassay developed by CEA and NG Biotech, for the qualitative detection of Candida auris. Isolates will be obtained from patients with suspected infection or cutaneous colonization, grown on selective media from routine clinical samples, with no additional sampling. Test results will be compared with the reference method, MALDI-TOF. Approximately 224 isolates from infected patients and 330 isolates from colnized patients will be included, allowing precise estimation of sensitivity and specificity with 95% confidence intervals. Results from the rapid test, MALDI-TOF identifications, and pictures of the test cassettes will be entered into an electronic case report form under unique pseudonymized identifiers. Statistical analysis will include contingency tables, calculation of sensitivity, specificity, positive and negative predictive values, and likelihood ratios with 95% confidence intervals. Inter-observer agreement will be measured using Cohen's kappa coefficient. The study will be conducted over a six-month inclusion period in a single center, the Clinical Microbiology Laboratory of Attikon University Hospital in Athens. The validation of this rapid test is expected to provide a reliable tool to support infection control measures and limit the nosocomial spread of Candida auris.
- Being tested
- NG-TestⓇ C.auris kit
- Keywords
- Candida auris, Diagnostic Tests, Routine, Immunochromatography, Microbiological Techniques, Sensitivity and Specificity, Microbial Drug Resistance, Fungal, Infection, Control
- Medical subject headings
- Candida auris infection, Cross Infection, Hypersensitivity, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NG-TestⓇ C.auris kitDiagnostic test
Evaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Candida auris and comparision with MALDI-TOF result (reference test)
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech, for detecting this pathogen using immunochromatography.
Sensitivity and specificity of the NG-Test® Candida auris rapid diagnostic test (RDT) will be assessed by comparison with the reference method (MALDI-TOF, Bruker) using colonies isolated prospectively from patients suspected of infection or colonization. The evaluation will also include a retrospective analysis using well-characterized isolates previously conserved by the microbiology department. Specificity will be assessed by testing a variety of non-Candida auris strains.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start25 May 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida Auris InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253311
- Sponsor's protocol ID
- APHP 250168
- Acronym
- DiagRaMIE Caur
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris DiagRaMIE C AURIS
- ClinicalTrials.gov ID
- NCT07253311
- Acronym / sponsor ID
- DiagRaMIE Caur / APHP 250168
- Keywords
- Candida auris, Diagnostic Tests, Routine, Immunochromatography, Microbiological Techniques, Sensitivity and Specificity, Microbial Drug Resistance, Fungal, Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- NG Biotech, Commissariat A L'energie Atomique
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Nov 2025 (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.
"Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings.
This study aims to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech. The test uses immunochromatography and can detect Candida auris in about 15 minutes. Its results will be compared to the reference method, MALDI-TOF, performed on colonies grown from routine patient samples.
Both retrospective (using stored isolates) and prospective (using new isolates) evaluations will be conducted. The study will measure the sensitivity and specificity of the test, and also include an assessment of its ease of use by laboratory staff. No additional samples will be collected from patients, and all testing will use de-identified isolates to ensure confidentiality."
Detailed description
This monocentric, non-randomized diagnostic accuracy study aims to evaluate the NG-Test® Candida auris, a lateral flow immunoassay developed by CEA and NG Biotech, for the qualitative detection of Candida auris. Isolates will be obtained from patients with suspected infection or cutaneous colonization, grown on selective media from routine clinical samples, with no additional sampling. Test results will be compared with the reference method, MALDI-TOF. Approximately 224 isolates from infected patients and 330 isolates from colnized patients will be included, allowing precise estimation of sensitivity and specificity with 95% confidence intervals. Results from the rapid test, MALDI-TOF identifications, and pictures of the test cassettes will be entered into an electronic case report form under unique pseudonymized identifiers. Statistical analysis will include contingency tables, calculation of sensitivity, specificity, positive and negative predictive values, and likelihood ratios with 95% confidence intervals. Inter-observer agreement will be measured using Cohen's kappa coefficient. The study will be conducted over a six-month inclusion period in a single center, the Clinical Microbiology Laboratory of Attikon University Hospital in Athens. The validation of this rapid test is expected to provide a reliable tool to support infection control measures and limit the nosocomial spread of Candida auris.
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
- The study population includes hospitalized patients suspected of Candida auris infection or cutaneous colonization.
Key inclusion criteria (4 listed)
- All isolates from the population that grow on the selective media: Sabouraud-dextrose (40g/L dextrose, 5.0g/L of peptic digest of animal tissue, 5.0 g/L of pancreatic digest of casein, 15.0 g/L of agar and final pH 5.6 ± 0.2) and CHROMagar™ Candida plus (manufactured by CHROMagar™, France). used in the hospital's routine diagnostic process.
- All isolates from the population that grow on the selective media: Salt-Sabouraud Dulcitol Broth (SSDB) with chloramphenicol and gentamicin (manufactured by S2 Media, United States), And the media used in the hospital's routine diagnostic process: Sabouraud Dextrose Liquid Medium containing NaCl 10%, chloramphenicol 50 mg/L.
Key exclusion criteria (1 listed)
- NA
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 |
|---|---|---|
| NG-TestⓇ C.auris kitEvaluation of the performance of the rapid diagnostic test (RDT) for the detection of the Candida auris and comparision with MALDI-TOF result (reference test) | Diagnostic test | – |
Primary outcome
to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech, for detecting this pathogen using immunochromatography.
Time frame: 1 day
Sensitivity and specificity of the NG-Test® Candida auris rapid diagnostic test (RDT) will be assessed by comparison with the reference method (MALDI-TOF, Bruker) using colonies isolated prospectively from patients suspected of infection or colonization. The evaluation will also include a retrospective analysis using well-characterized isolates previously conserved by the microbiology department. Specificity will be assessed by testing a variety of non-Candida auris strains.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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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.
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 Auris Infection and Candida Auris Colonization, run by Assistance Publique - Hôpitaux de Paris at 1 site in Greece.
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 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: looking for participants now, as of the sponsor's last update on 24 Jun 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 Greece. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thierry NAAS, PhD (1 45 21 29 86 ext. 33, thierry.naas@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed by CEA and NG Biotech, for detecting this pathogen using immunochromatography. (time frame: 1 day). 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 24 Jun 2026.