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临床试验/NCT07631351
NCT07631351已完成不适用

Epidemiological and Molecular Analysis of Scalp Ringworm in France With Antifungal Susceptibility Testing: A Multicenter Prospective Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 701 人开始时间: 2023年1月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
701
试验地点
1

研究概览

简要总结

Ringworm of the scalp or tinea capitis (TC) is the most common fungal infection in children. Few data are currently available in France concerning these infections, either on the distribution of the causative dermatophytes species or on the response to treatment. In addition, following the sudden cessation of the marketing of griseofulvin in March 2021, the only treatment with Marketing Authorization in France in children, the new recommendations recommend oral terbinafine or itraconazole. Yet, resistance of dermatophytes to terbinafine has appeared in France for a few years with recently reported cases of recalcitrant cutaneous dermatophytosis due to Trichophyton spp. imported from the Indian subcontinent. Moreover, the morphological identification of dermatophyte species is not always easy in routine practice, in particular within the T. interdigitale/mentagrophyytes/indotineae and Trichophyton rubrum/soudanense/violaceum complexes, the latter being frequently responsible for TC.

This study therefore aims to describe the epidemiology of TC in France from a clinical point of view, the responsible species and the response to treatment since the recent modification of therapeutic recommendations. To do this, a collection of data and isolates of dermatophytes responsible for TC in 11 French centers will be carried out during the year 2023. Then an epidemiological-molecular analysis of the isolates will be carried out as well as the determination of their sensitivity to antifungals searching for an acquired resistance.

详细描述

Objectives/Hypotheses The overall objective of this study is to describe the epidemiology of tinea capitis (TC) in France from clinical, species, and treatment response perspectives.

To achieve these objectives, it will be necessary to:

  • Identify isolates using various methods (morphological, proteomic, and molecular),
  • Perform phylogenetic analysis of the isolates,
  • Determine the susceptibility of isolates to four antifungal agents (terbinafine, itraconazole, voriconazole, and ketoconazole),
  • And, in the event that resistant isolates are identified, characterize the mechanisms of resistance to terbinafine and/or azoles.

Methodology Participating Centers Eleven centers (10 university hospitals and one private laboratory) were selected based on the results of two national surveys on TC conducted by the French Society for Medical Mycology (SFMM) between 2014 and 2019. Centers reporting at least 20 cases per year were included, ensuring at least one center per region. The estimated number of cases for 2023 is approximately 635.

The participating centers will be responsible for:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All dermatophyte isolates obtained from scalp sample cultures in the 11 centers between January 2, 2023, and December 31, 2023,

排除标准

  • 未提供

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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