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 summary

No information provided.

Study identification

• 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 Sharp & Dohme LLC

United States

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