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OpenTrials
Completed

NCT Number: NCT07270471

Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples.

Superficial fungal infections (onychomycosis, dermatophytosis, tinea, etc.) caused by dermatophytes are common in the general population, affecting 20-25% worldwide (1, 2). In our practice, the most frequently observed clinical presentation is onychomycosis, with a prevalence ranging from 2% to 16.7% (3). However, diagnosing this fungal infection is challenging due to its lack of specificity and the long culture turnaround time (up to one month). A molecular approach could overcome these two limitations.

Currently, upon sample receipt, a direct mycological examination is performed alongside culture on specific media. If culture is positive, species or genus identification is carried out. Thus, the current reference method is a positive direct examination and/or a positive dermatophyte culture. Over the past four years (2020-2023), 49.85% of samples analyzed in our laboratory were positive (direct exam ± culture).

Several PCR kits are available for molecular detection of dermatophytes in skin and keratinous samples, and initial studies report promising performance: sensitivity ranging from 78.5% to 96.5% and specificity from 89.1% to 100%.

The study aims to determine the role of molecular diagnostics in these mycodermatological conditions and to compare the performance of two commercial kits.

Primary objective:

Determine the diagnostic performance of two molecular techniques for detecting dermatophytes.

The reference technique (gold standard) will be the presence of dermatophytes established by direct fungal examination. If the direct examination is negative, fungal culture will be performed for confirmation.

Secondary objectives:

Compare the diagnostic performance of the two molecular biology kits. Compare the average turnaround time for results.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients consulting at CHRU Nancy for suspected dermatophyte infection.

Exclusion criteria

  • out CHRU Nancy

Treatment and study plan

PCR dermatophyte

Diagnostic Test

multiplex dermatophytes PCR

Primary outcomes

  1. dermatophytes : yes / no and species involved

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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