Clinical trial NCT05482763: Mycosis Culture Collection From Dermatological Isolated
Official title: Pilot Study on the Evaluation of the Efficacy, Tolerability and Safety of Topical and Oral Antifungals in the Treatment of Onychomycosis and Creation of a Library of Dermatological Clinical Isolates
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Onychomycosis
Resistant Infection
Nail Diseases
Keywords: Onychomycosis
Resistant Infection
Nail Diseases
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves the collection of biological material from patients with clinical suspicion of onychomycosis at an initial time, baseline T0, prior to the first administration of therapy according to the Italian guidelines, and evaluation with follow-up visits at 3,6,9 and 12 months of treatment (T3-T12).

Brief summary: This pilot, prospective, observational drug study aims to evaluate the efficacy, tolerability and safety of topical and oral antifungals in the treatment of onychomycosis caused by yeasts, dermatophytic moulds and non-dermatophytic moulds as well as correlate the scores in the MALDI-TOF method for the 'identification of genus and species of higher fungi utilizing the comparison between identification in direct optical microscopy, culture examination and optical microscopy and macroscopic and onychoscopic clinical aspects. Furthermore, an optional substudy will evaluate the drug resistance of clinical isolates using molecular or genetic methods.


Eligibility criteria: Inclusion Criteria:

* patients with clinical suspicion of onychomycosis.

Exclusion Criteria:

* Patients deemed unsuitable by the investigator
* Patients with documented sensitivity to study drugs such as azoles, allylamine, and ciclopirox olamine.
* Failure to adhere to topical or oral therapy;
* Replacement of the therapy reported in the study protocol;
* Voluntary decision by the patient

Primary outcomes:
measure: Change of Onychomycosis Severity Index (OSI)
timeFrame: week 0,12,24,36,52
measure: Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
timeFrame: Monitored from screening visit to end of study visit (52 week)
measure: Complete Cure at 12 months in the Target Toes
timeFrame: Week 52
Secondary outcomes:
measure: Change in Dermatology life Quality Index (DLQI)
timeFrame: week 0,12,24,36,52
measure: Patient Global Assessment
timeFrame: week 0,12,24,36,52
Other outcomes:
measure: Rate of correct classification by the test (MALDI-TOF MS profiling) from positive cultures
timeFrame: Week 0
measure: Rate of correct classification by KOH Test from clinical isolates
timeFrame: Week 0
measure: Rate of correct classification by direct Microscopy Test from positive cultures
timeFrame: Week 0
measure: Correlation between the identified fungi pathogens and the clinical course of the participants.
timeFrame: Week 52
Locations:
city: Rome
country: Italy
facility: Tor Vergata Univerisity Hospital
Study officials:
affiliation: University of Rome Tor Vergata
name: Elena Campione
role: PRINCIPAL_INVESTIGATOR
References: