Rapid test for Candida auris detection in hospital patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a monocentric, non-randomized diagnostic accuracy study evaluating the NG-Test Candida auris rapid diagnostic test against MALDI-TOF as the reference method. It uses both retrospective and prospective isolates from patients with suspected infection or skin colonization, with no additional patient sampling. The study will estimate sensitivity, specificity, predictive values, and likelihood ratios, and assess ease of use by lab staff, using de-identified data. Approximately 224 isolates from infected patients and 330 isolates from colonized patients will be analyzed over a six-month period at Attikon University Hospital in Athens. Results will inform infection control utility for limiting nosocomial spread.

Why it matters

Who can join: the full rules

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

Where it's running

• Attikon University Hospital
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Thierry NAAS, PhD
• Email: thierry.naas@aphp.fr
• Phone: 1 45 21 29 86

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.