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 range

0 Years – 18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

0 Years – 18 Years

Sex

ALL

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)