Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Astellas

Status

Completed

Conditions

Invasive Fungal Infections

Treatments

Drug: Micafungin

Study type

Observational

Funder types

Industry

Identifiers

NCT03174457

9463-MA-1006

Details and patient eligibility

About

The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.

Full description

The study will collect safety and efficacy data from pediatric patients who are prescribed intravenous micafungin for prophylaxis. During this trial, patients with two separate indications will be treated. The first, Invasive candidiasis will have a minimum treatment of 2 weeks. The second, Oesophageal candidiasis will have a minimum treatment of 1 week. Both indications will have a follow-up period of 4 weeks after treatment.

Enrollment

120 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Prescribed micafungin for prophylaxis or treatment of fungal infections.

According to treatment guidelines, micafungin may not be a suitable treatment for the following patients:

The patient has evidence of impaired liver function: alanine aminotransferase (AST), aspartate aminotransferase (ALT) >5 times the upper limit of normal (ULN) or total bilirubin >2 times ULN.
The patient has a history of allergy, hypersensitivity, or any serious reaction to the echinocandin class of antifungals.
The patient has a confirmed systemic fungal infection with a non-Candida species.

Exclusion criteria