Post Marketing Surveillance of Effectiveness (All-Cause Mortality) of Posaconazole Injection and Tablet Treatment of Invasive Aspergillosis in Chinese patients (MK-5592-141)

Study identification

• EU PAS number:
  EUPAS108481
• Study ID:
  199010
• Official title and acronym:
  Post Marketing Surveillance of Effectiveness (All-Cause Mortality) of Posaconazole Injection and Tablet Treatment of Invasive Aspergillosis in Chinese patients (MK-5592-141)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a multicenter observational study involving prospective and retrospective data collection from target hospitals using a case report form during the planned recruitment period. ; Chinese adult Invasive Aspergillosis (IA) participants who have been treated with posaconazole for at least 7 days in accordance with National Medicinal Products Administration’s (NMPA) approved product information are potential subjects for the study. ; Primary Objective: To assess all-cause mortality at Day 42 of IA in Chinese adult participants who receive at least 7 days of posaconazole injection and/or tablet formulations.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

10 centres, Merck Investigational Site, China

Study timelines

Date when funding contract was signed

Actual:16/08/2022

Study start date

Actual:22/09/2023

Data analysis start date

Planned:27/01/2025

Actual:24/01/2025

Date of final study report

Planned:30/06/2025

Actual:08/07/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable