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

Cutaneous antiseptic for Candida auris decolonization: randomized double-blind clinical trial to evaluate safety and efficacy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-10xv7t6b
Enrollment
Unknown
Registered
2023-10-01
Start date
2023-12-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Candidiasis

Interventions

This is a prospective, interventional, double-blind, randomized clinical study. A total of 70 patients who meet the eligibility criteria will be allocated into two intervention groups - group 1: exper

Sponsors

Centro de Ciências Médicas da Universidade Federal de Pernambuco
Lead Sponsor
Hospital da Restauração de Pernambuco Governador Paulo Guerra
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactReginaldo de Lima Neto

Universidade Federal de Pernambuco

reginaldo.limant@ufpe.br+5581991479644

Outcome results

None listed

Source: REBEC (via WHO ICTRP)