A description of the management of invasive fungal infections with oral posaconazole maintenance treatment following intravenous antifungal regimens in routine UK clinical practice (MAINTAIN)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6411
• EU PAS number:
  EUPAS6410
• Study ID:
  6411
• Official title and acronym:
  A description of the management of invasive fungal infections with oral posaconazole maintenance treatment following intravenous antifungal regimens in routine UK clinical practice (MAINTAIN)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A multi-centre, retrospective observational study to describe the current management of patients prescribed oral posaconazole as continuation therapy following previous intravenous (IV) antifungal treatment. Primary objective: To describe the population of patients prescribed oral posaconazole following previous IV antifungal treatment for possible, probable or proven invasive fungal infection (IFI). Secondary objectives: to describe, antifungal prophylaxis medications prior to treatment for IFI, IV antifungal treatments prior to posaconazole, dose/duration of posaconazole treatment, numbers and types of tests/investigations and NHS attendances during IV antifungal and posaconazole treatment, clinical outcomes at 12 months post-initiation of IV antifungal treatment. The study will involve retrospective collection of data from the medical records of patients (aged ≥18) prescribed oral posaconazole continuation treatment on/after 1st Jan 2010, following prior IV antifungal treatment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck & Co.

Birmingham Centre for Clinical Haematology Birmingham, UK, Leicester Royal Infirmary Leicester, UK, Centre for Clinical Haematology, Nottingham University Hospital Nottingham, UK

Study timelines

Date when funding contract was signed

Actual: 03/12/2012

Study start date

Actual: 20/01/2014

Data analysis start date

Planned: 30/06/2014

Date of final study report

Planned: 31/08/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Regulatory

• Was the study required by a regulatory body?:
  No