CompletedNot Applicable

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

Hong Kong, Singapore, South Korea120 participantsStarted 2017-06-21

Plain-language summary

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.

Who can participate

Age range0 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * The patient is receiving micafungin treatment in combination with other antifungal drugs.

What they're measuring

Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by incidence of Serious Adverse Events (SAEs)

Timeframe: Up to end of trial (up to 95 weeks)

Incidence of death attributable to micafungin treatment

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by vital sign measurements

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)

Timeframe: Up to end of trial (up to 95 weeks)

Trial details

NCT IDNCT03174457

SponsorAstellas Pharma Singapore Pte. Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-05-31

View on ClinicalTrials.gov More Invasive Fungal Infections trials

Who can participate

Age range0 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by incidence of Serious Adverse Events (SAEs)

Timeframe: Up to end of trial (up to 95 weeks)

Incidence of death attributable to micafungin treatment

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by vital sign measurements

Timeframe: Up to end of trial (up to 95 weeks)

Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment)

Timeframe: Up to end of trial (up to 95 weeks)