A description of the UK NHS hospital resource use and patient quality of life associated with hospitalisations for recurrent Clostridium difficile infection

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6414
• EU PAS number:
  EUPAS6413
• Study ID:
  6414
• Official title and acronym:
  A description of the UK NHS hospital resource use and patient quality of life associated with hospitalisations for recurrent Clostridium difficile infection
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  A multi-centre, non-interventional study to describe UK hospital resource use and quality of life (QoL) associated with hospitalisations for recurrent Clostridium difficile infection (CDI). Primary objective: to describe the cost of hospital resource use of patients with a CDI recurrence. Secondary objectives: to determine the number of days hospitalised for CDI recurrence, the cost of hospital resource between CDI episodes and to describe QoL of patients hospitalised for CDI. The study has two parts: 1) Retrospective collection of clinical/resource use data from medical records of patients who have had a first CDI episode and are hospitalised with a recurrence within 12 weeks of end of treatment of first episode (cases) or have not had a recurrence within 12 weeks (matched controls). 2) Prospective assessment of health-related QoL of patients hospitalised for CDI, through patient-completion of the EQ5D-3L questionnaire, with recording of demographic details from medical records.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Merck & Co.

Royal Free Hospital

Leeds General Infirmary Leeds, UK, The Royal Free Hospital London, UK, Glasgow Royal Infirmary Glasgow, UK, Royal Sussex County Hospital Brighton, UK, Sunderland Royal Hospital Sunderland, UK, Manchester Royal Infirmary Manchester, UK

Study timelines

Date when funding contract was signed

Actual: 13/11/2012

Study start date

Actual: 23/09/2013

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