Study identification

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 Sharp & Dohme LLC
United States
First published:
08/07/2025
Institution Pharmaceutical company
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

Contact details

Mark Wilcox

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
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