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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multicenter observational study

Study drug and medical condition

• Name of medicine:
  NOXAFIL
• Study drug International non-proprietary name (INN) or common name:
  POSACONAZOLE
• Anatomical Therapeutic Chemical (ATC) code:
  (J02AC04) posaconazole

  posaconazole
• Medical condition to be studied:
  Aspergillus infection
• Additional medical condition(s):
  Invasive Aspergillosis

Population studied

• Short description of the study population:
  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 (≥18 years old) who have been treated with posaconazole, as an injection and/or tablet formulation, for at least 7 days in accordance with National Medicinal Products Administration’s (NMPA) approved product information are potential subjects for the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  55

Study design details

• Study design:
  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. Participants include Chinese adults with IA who have received posaconazole treatment for at least 7 days.
• Main study objective:
  The aim of this study is to assess all-cause mortality of posaconazole injection and tablet treatment of Invasive Aspergillosis (IA) in Chinese participants by an observational study involving prospective and retrospective data from target hospitals using a case report form during the planned recruitment period.
• Setting:
  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. Participants include Chinese adults with IA who have received posaconazole treatment, as an injection and/or tablet formulation, for at least 7 days. Relevant patient-level information will be collected from multiple information systems, including electronic medical record (EMR), paper medical records, Hospital Information System (HIS), Laboratory Information System (LIS), and routine patient management material from clinicians in selected hospitals. Hospitals in which posaconazole injection and/or tablet is available and have the most patients using this product will be considered for inclusion in the study.
• Comparators:
  The study of interest is posaconazole injection and/or tablet formulations treatment administered in a non-interventional setting. The study will include Chinese adult participants who received posaconazole injection and/or tablet formulations treatment in routine clinical practice.
• Outcomes:
  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. To assess overall response rate in Chinese adult IA participants and those with disease refractory to amphotericin B, voriconazole, itraconazole or isavuconazole, or other antifungal medications with activity against Aspergillus. To describe baseline demographics, clinical characteristics and treatment patterns in Chinese adult participants with first line posaconazole treatment or salvage treatment of IA.
• Data analysis plan:
  The primary objective of all-cause mortality will be calculated with 95% confidence interval (CI). The secondary objectives of overall response rates at the end of posaconazole treatment will be described by percent with 95% CI in the participants with proven or probable IA participants by treatment line. These analyses will be stratified by data collection method: prospective versus retrospective. Variables for Demographic and Clinical Characteristics and Treatment Patterns by treatment lines will be described among participants in the study population overall and separately by treatment line. A descriptive analysis of the distribution of values abstracted for each variable will be provided. Continuous variables that will be calculated are mean/median, standard deviation (SD), min/max, and interquartile range (IQR, including the first quartile [Q1] and third quartile [Q3]). The frequency and percentages will be calculated for these variables.