Tag Archives: EUCLID study

C. difficile Infection CDI – European Clinician Consensus Report with Recommendations for Improved Management of CDI

Largest Ever European Clinician Consensus Report on Clostridium Difficile Infection Provides Recommendations for Improved Management of CDI

Clostridium difficile infection (1) ,a potentially fatal disease,[2] is at least twice as common as MRSA infections in hospitals[3],[4]and is estimated to cost the EU EUR3 billion per annum[5]

A first of its kind expert consensus report on Clostridium difficile infection (CDI), contributed to by more than 1,000 healthcare professionals across Europe, has been presented today at the Healthcare Infection Society (HIS) International Congress in Lyon, France.[1]

The consensus report aimed to identify a set of expert views on CDI management, in order to determine attitudes to diagnosis, treatment and outcomes of CDI and to identify perceived unmet clinical needs.[1]

Based on the consensus scores of the 1,047 respondent clinicians, recommendations have been suggested to further develop CDI services to ensure appropriate diagnosis and treatment strategies are applied across all healthcare settings in Europe.

Agreed recommendations include: [1]

- Implementation of clearly defined algorithms for stool specimen selection,
  collection and testing
- Better definition of how optimal CDI treatment can be planned for patients
  with co-morbidities
- Improved antibiotic stewardship, including education for all healthcare
  professionals and ensuring national policies warrant consistent surveillance,
  prevention, diagnosis and treatment of CDI across Europe.

Dr Nicola Petrosillo, Italy, commented: “The biggest problem we face in treating CDI is recurrence. Not only does recurrent CDI cause increased patient suffering, but it also significantly raises healthcare costs. A German study has shown that costs for treating CDI patients are over EUR7,000 more than the costs for treating patients without CDI. The recommendations put forward as a result of this survey could help to ensure appropriate diagnosis and treatment strategies are applied at a national and European level to improve patient outcomes and reduce the economic burden of this potentially fatal disease.”

A consortium of leading European experts prepared a series of 29 statements representing their collective views on the diagnosis and management of CDI in Europe. Consensus statements focused specifically on diagnosis of CDI; definitions of severity; treatment failure, recurrence and its consequences; infection prevention and control interventions; antimicrobial stewardship and education; and national CDI clinical guidance and policy.[1]

Questionnaires were completed by 1,047 clinicians involved in managing CDI from Germany, France, Spain, Italy, Sweden and the United Kingdom. The clinicians, from specialities such as infectious diseases, internal medicine and intensive care, indicated their levels of agreement with each of the statements. Levels of agreement exceeded the 66% threshold for consensus for 27 out of 29 statements (93.1%), indicating strong support for the majority. Variance between countries and specialties was analyzed and showed strong alignment with the overall consensus scores.[1]

Other recommendations resulting from the consensus include strengthening the definitions for the severity of CDI, in particular severe and non-severe CDI; increased collaboration of hospitals and community-based health and social care services to improve CDI management; and appropriate resourcing and robust application of infection control interventions to limit the transmission of CDI.[1]

“Patients who suffer from CDI tend to be those who are already extremely vulnerable, such as cancer patients, people who have received immunosuppressants or antibiotics, and those who have had recent surgery,” said Doctor Simon Goldenberg, Guy’s and St Thomas’ NHS Foundation Trust, London. “This survey is important because it identifies the views of healthcare professionals who are actively involved in the day-to-day testing, diagnosis and treatment of CDI and who are responsible for reducing transmission and recurrence rates.”

CDI is one of the most common causes of antibiotic-associated diarrhea and severe cases can lead to bowel surgery and even death.[2] 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.[6],[7] Recurrence is a major challenge in CDI treatment, 25% of CDI patients suffer a recurrence within one month[8],[9],[10] and patients who have already had one recurrence have a 40% risk of a further episode of CDI.[11]

NOTES TO EDITORS
About Astellas Pharma EMEA

Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business 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’s focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.

References:

1) Aguado, J.M et al. The Consensus Views of European Healthcare
  Professionals: Addressing Clostridium difficile infection. Poster presented at HIS
  2014.
2) Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk
  factors and management. Nat Rev Gastroenterol Hepatol. 2011;8:17-26.
3) UK Health Protection Agency. English national point prevalence survey on
  healthcare-associated infections and antimicrobial use, 2011: preliminary data.
  London; Health Protection Agency, 2012
4) Meyer E, Gastmeier P, Weizel-Kage D, et al. Associations between nosocomial
  meticillin-resistant Staphylococcus aureus and nosocomial Clostridium
  difficile-associated diarrhoea in 89 German hospitals. J Hosp Infect 2012;82:181-6.
5) Kuijper EJ et al. ESCMID study group for Clostridium difficile. Emergence of
  Clostridium difficile associated disease in North America and Europe. Clin Microbiol
  Infect. 2006;12:2-18.
6) Oake N, et al. The effect of hospital-acquired Clostridium difficile
  infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
7) Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized
  patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect
  Dis. 2013;56:1108-16.
8) Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium
  difficile Toxins. N Engl J Med. 2010;362;3:197-205.
9) Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin
  and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin
  Micro Infect. 2008;14(Suppl 7):S103-4.
  10) Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile
  infection. N Engl J Med. 2011;364:422-31.
  11) Kelly CP, LaMont JT. Clostridium difficile - more difficult than ever. N
  Engl J Med. 2008;359(18):1932-1940.
  12) Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults.
  CMAJ 2004;171:51-8.
  13) Crobach MJ, et al. European Society of Clinical Microbiology and Infectious
  Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium
  difficile-infection (CDI). Clin Micro Infect 2009;15:1053-1066.
  14) Pepin J, et al. Increasing risk of relapse after treatment of Clostridium
  difficile colitis in Quebec, Canada. Clin Infect Dis 2005;40:1591-7.
  15) Bauer MP, et al. European Society of Clinical Microbiology and Infectious
  Disease (ESCMID): treatment guidance document for Clostridium difficile-infection
  (CDI). Clin Micro Infect 2009;15:1067-79.

Date of preparation: November 2014

Contact:

Donna Wright, Ruder Finn, dwright@ruderfinn.co.uk, Tel:
+44(0)20-7438-3085 Mindy Dooa, Astellas Pharma EMEA

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C. difficile Infection: EUCLID Study Reveals >39K Cases May Be Missed Yearly

* IN THE NEWS:  12 MAY 2014  *

 

EUCLID Study Reveals More Than 39,000 Cases of Clostridium difficile Infection  May Be Missed Each Year

 

Clostridium difficile is the major cause of infective, hospital-acquired diarrhoea in the developed world1

BARCELONA, SPAIN, 12 MAY 2014, PRNewswire/- The full set of data from EUCLID, the largest ever prevalence study of Clostridium difficile infection (CDI) across Europe, were presented today at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID). Data from 482 European hospitals reveal that in a single day, an average of 109 cases of CDI are missed due to a lack of clinical suspicion or inadequate laboratory testing, potentially leading to more than 39,000 missed cases in Europe each year.2

The study results show that incidence of CDI in Europe has increased (compared with previous studies) from 4.123 to 7.92 cases per 10,000 patient bed days between 2008 and 2012-13, respectively. Furthermore, the new data highlight that CDI PCR-ribotype 027, one of the most virulent PCR-ribotypes associated with CDI epidemics,4 is the most common in Europe.5 Countries with the highest rates of CDI testing had the lowest rates of this epidemic C. difficile strain.5

“Countries with increased awareness of CDI have probably been able to reduce outbreaks associated with the most virulent C. difficile strains by improving the early diagnosis of this usually healthcare associated infection” said Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. “This study highlights that it is essential that we improve the implementation of CDI testing in hospitals, in order to tackle the issue of the increasing incidence of CDI across Europe.”

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.

These full results compare data captured on two separate days, one in winter 2012/13 and one in summer 2013. On each of the assigned days, participating hospitals submitted all received unformed faecal samples to the respective EUCLID National Coordinating laboratories (NCLs). In total, 7,181 faecal samples were submitted by participating hospitals.2

Results of this study highlight marked recent shifts in CDI testing policy and methodology across Europe, resulting in improved testing policies and selection of laboratory methods.2 The data show that false-positive rates decreased between the two study days in those countries where testing procedures and methods had improved.2 Despite this, more than 50% of hospitals are still not using the most accurate testing procedure for CDI and more than one in five (21.8%) samples found to be positive for CDI at the NCL had not been tested at the local hospital level.2 In addition, the findings reveal that over half (52.1%) of hospitals in Europe only test for CDI at a physician’s request.2

“Guidelines recommend that hospitals test for CDI on all unformed stools when the cause of diarrhoea is not clear. However we are still seeing an issue with both a lack of clinical suspicion and lack of testing for CDI”, commented Professor Mark Wilcox. “CDI is a condition which causes considerable suffering for patients and a huge economic burden to hospitals across Europe. These results reveal that there is still more to be done in order to optimise CDI management and prevention.”

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 was initiated and financially supported by Astellas Pharma Europe Ltd.

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.6 Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.7 CDI is the leading cause of hospital acquired (nosocomial) diarrhoea in industrialised countries8 and the risk of CDI and disease recurrence is particularly high in patients aged 65 years and older.9 Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.10,11,12 The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.13

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.

References

  1. Ananthakrishnan AN. Clostridium difficile infection: epidemiology, risk factors and management. Nat Rev Gastroenterol Hepatol 2011;8:17-26.
  2. Davies KA, et al. Second report from the EUropean, multi-centre, prospective bi-annual point prevalence study of Clostridium difficile infection in hospitalised patients with Diarrhoea (EUCLID) PO753. Presented at ECCMID 2014.
  3. Bauer MP et al. Clostridium difficile infection in Europe: a hospital-based survey. Lancet 2011; 377:63-73.
  4. Kuijper EJ, Coignard B, Tull P. Emergence of Clostridium difficile-associated disease in North America and Europe. Clin Microbiol Infect 2006;12 suppl 6:2–18.
  5. Davies KA. Increased diversity of C. difficile PCR-ribotypes across European countries and disparity of 027 prevalence; results of a European prevalence study of Clostridium difficile infection (EUCLID). Presented at ECCMID 2014.
  6. Poutanen SM, et al. Clostridium difficile-associated diarrhoea in adults. CMAJ 2004;171:51–8.
  7. Kelly CP, et al. Clostridium difficile infection. Ann Rev Med 1998;49:375–390.
  8. Crobach MJ, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): Data review and recommendations for diagnosing Clostridium difficile-infection (CDI). Clin Micro Infect 2009;15:1053–1066.
  9. Pepin J, et al. Increasing risk of relapse after treatment of Clostridium difficile colitis in Quebec, Canada. Clin Infect Dis 2005;40:1591–7.
  10. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycin and metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect 2008;14(suppl 7):S103-4.
  11. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. N Engl J Med 2010;362;3:197-205.
  12. Louie TJ, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011;364:422–31.
  13. Bauer MP, et al. European Society of Clinical Microbiology and Infectious Disease (ESCMID): treatment guidance document for Clostridium difficile-infection (CDI). Clin Micro Infect 2009;15: 1067-79.

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 was initiated and financially supported by Astellas Pharma Europe Ltd.

FDX/14/0017/EUf
Date of Prep: May 2014