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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48543
• EU PAS number:
  EUPAS37495
• Study ID:
  48543
• Official title and acronym:
  A non comparative , multi centre observational study: Isavuconazole (Cresemba) in Invasive Mould Infections (Invasive Aspergillosis, Invasive Mucormycosis) in India
• DARWIN EU® study:
  No
• Study countries:
  India
• Study description:
  This is a non-comparative, multi centre, observational study. Adult patients with proven, probable or possible Invasive Aspergillosis or Invasive Mucormycosis as decided by the treating clinician and receiving Isavuconazole (Cresemba) (iv,oral) as per standard of care practices will be recruited from tertiary care centers across India. Outcomes: clinical outcome, microbiological outcomes, length of hospital stay, and discharge status. Key covariates: patient demographics, indication, treatment history, clinical characteristic. Data will be abstracted for patients in the study, from patient charts/ electronic health records after end of six weeks. The data will be recorded in the case report forms (CRFs) for further evaluation. Data will be collected from a maximum of 70 patients with diagnosis of proven, probable or possible IMI, as decided by the treating clinician, during a period of two consecutive calendar years from the protocol approval. The study population will be stratified to achieve a number of study subjects of about 50 Invasive Aspergillosis (IA) and about 20 for Invasive Mucormycosis (IM) on IV and/or oral Cresemba formulations.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pfizer

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/01/2021

Actual: 29/01/2021

Study start date

Planned: 01/10/2021

Actual: 10/01/2022

Date of final study report

Planned: 31/12/2022

Actual: 30/11/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C3791010_Study Protocol_11.09.2020

Updated protocol

C3791010_Revised Study Protocol_Final_Version 5.0

Regulatory

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

Other study registration identification numbers and links

C3791010