Evaluation of Two Dermatophyte qPCR Kits on Skin and Keratinous Samples.
NCT ID: NCT07270471
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
120 participants
OBSERVATIONAL
2024-12-27
2025-11-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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PCR dermatophyte
multiplex dermatophytes PCR
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Central Hospital, Nancy, France
OTHER
Responsible Party
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Anne DEBOURGOGNE
PU-PH
Locations
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CHRU Nancy
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2024-PI-081
Identifier Type: -
Identifier Source: org_study_id
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