A non comparative , multi centre observational study: Isavuconazole (Cresemba) in Invasive Mould Infections (Invasive Aspergillosis, Invasive Mucormycosis) in India

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Additional data on post-marketing use of Cresemba in Indian patients
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm, multicenter, observational study

Study drug and medical condition

• Name of medicine:
  CRESEMBA
• Medical condition to be studied:
  Aspergillus infection

  Mucormycosis

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with invasive aspergillosis/invasive mucormycosis treated with isavuconazole (Cresemba).; Inclusion criteria:; 1. Patients 18 years or older; 2. Patients with diagnosis of invasive aspergillosis/invasive mucormycosis meeting the criteria for proven, probable or possible invasive mould disease as per the judgement of the treating physician and must have received Cresemba for at least 48h .; ; Exclusion criteria:; There are no other exclusion criteria for this study.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  70

Study design details

• Main study objective:
  To describe a case series of patients treated with Isavuconazole (Cresemba) (post approval) for Invasive Mould Infections (Invasive Aspergillosis, Invasive Mucormycosis) in India during a period of two years (post protocol approval)
• Data analysis plan:
  Descriptive statistics on the study population. Data will be analyzed using standard statistical methods: variables will be described with medians interquartile ranges (IQR), and data analysis will be performed using SPSS software.

Documents

Study results

Cresemba NI PASS_Summary