NCT07253311 Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris
| NCT ID | NCT07253311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Candida Auris Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 554 participants |
| Start Date | 2026-05-25 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 554 participants in total. It began in 2026-05-25 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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."
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: * NA
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07253311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Candida Auris Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07253311 currently recruiting?
Yes, NCT07253311 is actively recruiting participants. Contact the research team at thierry.naas@aphp.fr for enrollment information.
Where is the NCT07253311 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07253311 clinical trial?
NCT07253311 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 554 participants.