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

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

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.

Study Overview

• Status: Completed
• Conditions: Invasive Fungal Infections
• Intervention / Treatment: Drug: Micafungin

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Hong Kong
  • New Territories, Hong Kong
    • Site HK203
  • Pok Fu Lam, Hong Kong
    • Site HK202
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Site KR401
  • Seoul, Korea, Republic of
    • Site KR402
  • Seoul, Korea, Republic of
    • Site KR403
  • Seoul, Korea, Republic of
    • Site KR404
• Singapore
  • Singapore, Singapore
    • Site SG801
• Taiwan
  • Changhua, Taiwan
    • Site TW606
  • Taichung, Taiwan
    • Site TW603
  • Taichung, Taiwan
    • Site TW605
  • Taipei, Taiwan
    • Site TW601
  • Taipei, Taiwan
    • Site TW604
  • Taoyuan, Taiwan
    • Site TW602
• Thailand
  • Bangkok, Thailand
    • Site TH701
  • Bangkok, Thailand
    • Site TH703
  • Chiang Mai, Thailand
    • Site TH704

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Paediatric patients for whom micafungin is prescribed for prophylaxis or treatment of fungal infections

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment: micafungin; Participants receive once daily by intravenous infusion.	Drug: Micafungin; Intravenous; Other Names: Mycamine; FK463; micafungin sodium

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Astellas Pharma Singapore Pte. Ltd.
• Investigators: Study Director: Medical Director, Astellas Pharma Singapore Pte. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Micafungin; Candidemia; Paediatric; Aspergillosis; Invasive Candidiasis; Oesophageal Candidiasis; Prophylaxis of Candida Infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: 9463-MA-1006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes