Largest EU Prevalence Study of Clostridium Difficile Infection Reveals That More Than One Fifth of Patients May Receive Wrong Diagnosis
BERLIN, Germany, April 27, 2013 /PRNewswire/ --
Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare acquired infections[1], at least twice as common as MRSA infections in hospitals[2],[3]
First results from EUCLID, the largest ever prevalence study of CDI across Europe, were presented today at the 23rd European Congress of Clinical Microbiology and Infectious Disease (ECCMID). Data reveal that an incorrect diagnosis may be made for more than one in five hospitalised patients with diarrhoea, who could have CDI.[4] This potentially may lead to inappropriate or inadequate treatment.[4] CDI can be severe and hospital patients with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[5],[6]
The EUropean multi-centre, prospective bi-annual point prevalence study of CLostridium difficile Infection in hospitalised patients with Diarrhoea (EUCLID) involved 482 hospitals from 20 European countries. In total 3,920 faecal samples were submitted by participating hospitals to the EUCLID National Coordinating laboratory (NCLs). Nearly one in four (24.6%) samples found to be positive for C. difficile at the NCL had not been tested at the local hospital level and 47 (2.3%) patients found to be positive for C. difficile at the NCL were tested at the hospital but received an incorrect negative result. Notably, only 10.6% of hospitals tested all diarrhoeal faecal in-patient samples, and only 27.4% used an optimised CDI algorithm for routine testing.[4]
"In this study we saw that on one day alone, 82 patients with CDI were not diagnosed due to a lack of laboratory testing or clinical suspicion, and in total 246 patients received an incorrect result", said Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. "These results show that there is still more to be done to improve the way CDI is currently being tested in hospitals across Europe."
The EUCLID study is being coordinated out of the University of Leeds, UK, by Professor Mark Wilcox's research group, with support from the EUCLID Core Group. The study is funded by Astellas Pharma Europe Ltd. Participating hospitals submitted samples of all un-formed faeces received on a single day to the NCL regardless of whether they had been tested within the hospital. Each NCL then tested all samples using a 2-stage CDI algorithm, with the results from the hospital and NCL then compared for each sample.[4]
In this study, the average incidence rate of CDI across Europe was 6.6 per 10,000 patient bed days.[4] This is substantially higher than a previous pan-European surveillance study, the European Clostridium Infection Survey (ECDIS) performed in 2008-2009 which found an average incidence rate of 4.1 per 10,000 patient bed days.[7] There were also wide discrepancies between the numbers of samples tested for C. difficile within hospitals; the highest rate of 97% of samples tested was found in the Czech Republic with the lowest of 0% in Bulgaria.[4] Surprisingly hospitals in the UK only tested 75% of samples despite national guidance to test all unformed stools from inpatients.[4]
"CDI is an important patient safety issue and also creates a significant economic burden for hospitals and health systems", comments Professor Mark Wilcox. "It is important that optimal methods of diagnosis are in place, as errors may lead to inappropriate or inadequate treatment of patients and inadequate infection control measures."
A second sampling and testing wave will take place during the Summer of 2013 with the full results and analysis expected to be available in 2014.
About Clostridium difficile Infection
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.[8] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.[8],[9] CDI is the leading cause of hospital acquired (nosocomial) diarrhoea in industrialised countries[10] and the risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.[11]Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.[12],[13],[14] The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.[15]
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. As a global company, Astellas is committed to combining outstanding research and development (R&D) and marketing capabilities to continue to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. manages 21 affiliate offices located across Europe, the Middle East and Africa. In addition, the Company has an R&D site and three manufacturing plants in Europe. 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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