Skin cleansing soap with Candida auris: clinical trial to evaluate safety and efficacy

Phase 1

• Conditions: Cutaneous Candidiasis; C01.150.703.160

• Registration Number: RBR-10xv7t6b
• Lead Sponsor: Centro de Ciências Médicas da Universidade Federal de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-10-01
• Last Update Posted: 16 October 2023
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients hospitalized in the Intensive Care Units of the Hospital da Restauração who have skin colonization with Candida auris confirmed by the hospital's clinical analysis laboratory, aged 18 years or older, without limitation of gender and race and who have signed the Term of Free and Informed Consent - TCLE

Exclusion Criteria

Patients with a previous diagnosis of superficial or invasive mycosis and who are using antifungal therapies

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A new antiseptic derived from pyridyl-thiazolidinone is expected to be safe and effective for skin decolonization by Candida auris, verified by means of the fungal isolation method and microbial count, based on the verification of a variation in the growth rate of colonies pre and post intervention.

Secondary Outcome Measures

Name	Time	Method
It is expected to help public policies in the State of Pernambuco aimed at controlling and preventing outbreaks of fungal infections through the identification of clinical strains of Candida auris using a chromogenic and proteomic approach and mapping of the main risk factors involved in cases of colonization.