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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Conditions
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Invasive Fungal Infections

Intervention / Treatment
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* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment: micafungin<br>Participants receive once daily by intravenous infusion. | Drug: Micafungin<br>* Intravenous<br>* Other names: FK463;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period | ADR is considered to be any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship (drug-event) is at least a reasonable possibility | Up to end of trial (up to 95 weeks) | 
| Safety assessed by incidence of Serious Adverse Events (SAEs) | Adverse event (AE) is considered serious if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event | Up to end of trial (up to 95 weeks) | 
| Incidence of death attributable to micafungin treatment | Death, if considered by the clinician to be attributable to micafungin | Up to end of trial (up to 95 weeks) | 
| Safety assessed by vital sign measurements | Vital sign measurements include systolic and diastolic blood pressure, pulse rate, and body temperature | Up to end of trial (up to 95 weeks) | 
| Safety assessed by AEs of special interest (stratified by relationship to micafungin treatment) | This includes hepatic dysfunction, renal dysfunction, infusion-related reactions, haemolytic events, histamine-release/allergic-type reactions and injection site reactions | Up to end of trial (up to 95 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by nature, frequency and severity of Adverse Events (AEs) | Adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). AEs that started or worsened during the observational period after the start of micafungin treatment will be summarized by the time period of onset. AE occurring within 3 days after end of therapy will be defined as treatment emergent adverse events | Up to end of trial (up to 95 weeks) | 
| Overall treatment success | The overall treatment success will be defined as a complete or partial clinical response in proven fungal infection, and by an empirical treatment composite outcome score in probable/possible fungal infection. Overall treatment success for patients receiving prophylactic treatment is defined as the absence of proven, probable, possible or suspected Invasive Fungal Infection (IFI) during the period of prophylactic therapy and up to 4 weeks after stopping micafungin administration | Up to end of trial (up to 95 weeks) | 
| Change from baseline to end of treatment in safety laboratory parameters | Indication of hepatic or renal dysfunction | Up to end of trial (up to 95 weeks) | 
| Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species | Response will be defined as eradication, presumed eradication, or overall | Up to end of trial (up to 95 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oesophageal Candidiasis, Paediatric, Invasive Candidiasis, Prophylaxis of Candida Infections, Candidemia, Aspergillosis, Micafungin