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

Study identification

• EU PAS number:
  EUPAS17838
• Study ID:
  33002
• Official title and acronym:
  Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania – ERADICATE Study
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Hong Kong

  Indonesia

  Korea, Republic of

  Malaysia

  Singapore

  Taiwan

  Thailand
• Study description:
  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.The primary objective of this study is to evaluate the safety of micafungin when prescribed for prophylaxis or treatment of fungal infections in paediatric patients in Asia/Oceania.The secondary objective of this study is to evaluate the efficacy of micafungin in sub-groups of paediatric patients in Asia/Oceania for (1) the prophylaxis of fungal infections, and (2) treatment of proven/probable/possible fungal infections using the European Organization for Research and Treatment of Cancer (EORTC) criteria.
• Study status:
  Finalised

Research institutions and networks

Institutions

Astellas Pharma Global Development, Inc.

Study timelines

Date when funding contract was signed

Actual:24/12/2016

Study start date

Planned:30/06/2017

Actual:21/06/2017

Data analysis start date

Planned:12/01/2019

Actual:01/06/2018

Date of final study report

Planned:29/11/2019

Actual:25/02/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astellas Pharma Singapore Pte Ltd

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only