Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

Recruiting now

Conditions studied: Candida Auris Infection, Candida Auris Colonization, Nosocomial Infections

In brief

"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."

Key facts

Study ID: NCT07253311
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 554
Starts: 2026-05-25
Expected to finish: 2026-10-31
Last updated by the study team: 2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Where it is running

Attikon University Hospital — Athens, Greece (enrolling)

Full record on ClinicalTrials.gov

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