Largest Ever Study of Clostridium Difficile Infection to Attempt to Reveal True Incidence Of Disease

CHERTSEY, England, December 3, 2012 /PRNewswire/ --

Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare acquired infections^[1]

Today marks the launch of the EUropean, multi-centre, prospective bi-annual point prevalence study of CLostridium difficile Infection in hospitalised patients with Diarrhoea (EUCLID), the largest study of the prevalence of CDI ever conducted in Europe. For the first time experts will get a clear picture of the true incidence of CDI; a significant cause of morbidity and mortality and a condition that is thought to be widely under-estimated.^[2],[3]

CDI is the leading cause of infectious diarrhoea in industrialised countries^[4] and is estimated to kill one in 50 patients affected.^[3] CDI represents a huge economic burden,^[5] patients who develop CDI stay in hospital an extra 1-3 weeks^[5],[6],[7] at an estimated additional cost of €7,147^[5] compared to those without CDI. The incidence and severity of CDI continues to increase.^{[3],[8],[9],[10],[11]} The most recent large-scale prevalence study was carried out in Spain in 2008 and looked at the number of CDI cases within the general population at a certain time. Results revealed that two thirds of cases of CDI were either not picked up or were misdiagnosed within the hospital due to low clinical awareness of CDI.^[2]

The EUCLID study, which involves 20 European countries and approximately 500 hospitals, aims to identify the underlying incidence of CDI in hospitalised patients with diarrhoea and highlight the extent of under-testing and under-diagnosis per country. The study was initiated and sponsored by Astellas Pharma Europe Ltd and endorsed by the European Society of Clinical Microbiology and Infectious Diseases study group for Clostridium difficile (ESGCD).

"This study represents an important step forward in understanding the true incidence of CDI and will provide us with much needed information about the epidemiology of a debilitating disease in Europe," said Dr Ed Kuijper, Chairman of the ESCMID study group for Clostridium difficile.  

The EUCLID study will be coordinated out of University of Leeds and Leeds Teaching Hospitals NHS Trust, UK, under Professor Mark Wilcox, with support from the EUCLID Core Group. The study is funded by Astellas Pharma Europe Ltd. In each of the participating 20 countries, hospitals will submit samples of all un-formed faeces received on a specified day to a national coordinating laboratory where they will be tested for CDI using a standardised protocol. The sampling will be performed at two different time points in the year to reflect seasonal variations in CDI which peaks during the winter months.^[12] Data will also be collected on any diagnostic CDI test(s) requested within the hospital for each sample submitted and if so, the test used and the result. These data, along with reported CDI rates from the previous year, will be used to calculate the level of under-recognition and under-diagnosis.

A full report and analysis of the findings will be published at the end of the EUCLID study which is anticipated in mid-2013.

Notes to Editors:

About Clostridium Difficile Infection (CDI)

CDI is a serious illness resulting from infection of the internal lining of the colon by C. difficile bacteria. The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.^[13] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.^[13],[14] The risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.^[15] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.^{[16],[17],[18]} ESCMID has identified recurrence as being the most important problem in the treatment of CDI.^[19] CDI represents a huge economic burden,^[5] patients who develop CDI stay in hospital an extra1-3 weeks^[5],[6],[7] at an estimated additional cost of €7,147^[5] compared to those without CDI.

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is the European headquarters of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,300 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.

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